Posted Wed, 10 Apr 2024 07:00:34 GMT by Venkata Subba Raju Balaraju Dr
For submitting mandatory documents to EMA GCP inspectors, is there any available format for sharing the information? Kindly help me if you have one. 
Posted Wed, 10 Apr 2024 12:40:22 GMT by Paolo Tomasi EMA
For documents to be uploaded to IRIS submissions, XML-based file formats are preferred, e.g. .docx, .xlsx, .pptx.
As described in the IRIS guide to applicants (creation of submissions), while there is no maximum number of files or global size, there is a size limit of 50 Mb per individual file. Please upload individual files for each document, rather than a single Zip file (or similar) for the set of all documents; it is possible to upload multiple files in a single operation.
If appropriate, for example for literature references, you can merge several PDF files into a single one, using specific software, before uploading. A Zip file is recommended only as the container for the literature references, as an alternative to a single PDF; all other documents should be uploaded individually.

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