E-Submission Guidance Updates
Updates to e-submission guidance including instructions for Dossier-formatted submissions.
For all e-submissions
1. All MRIDs for a specific 6-digit root MRID must be in the same zip file.
2. Each document must be submitted as a single file. This is directed mainly for large studies that typically, in paper format, would be split up into multiple physical volumes.
3. Do not include the same document in multiple zip files. Likewise, do not include a reference in the XML file to a document that is not physically included in the zip file. If a document supports multiple products, reference the document on the data matrix, transmittal, or other document (e.g. cover letter) as appropriate. e-Submission is not intended to provide cross-reference information and is merely a mechanism to get documents to the EPA.
4. There is a file size limit for the zip files. Restrict each zip file to less than 2 GB. If a submission will be larger than that size, submit two separate zip files each with its own xml file and corresponding documents.
5. If a CSF requires an “addendum”, include the addendum at the back of the CSF as part of the CSF file and submit as a single document.
6. Do not use “&”, “<”, and “>” in the xml file. Also, restrict characters to those in the UTF-8 character set. Typical examples of characters that are not part of the UTF-8 character set include ™, ®, ©, (M-dash), – (n-dash). Do not confuse the normal hyphen (allowed) with the M-dash and N-dash symbols (disallowed).
7. Study summaries that have a one-to-one relationship with the study do not require their own MRIDs but should reference the MRID of the study they are summarizing. Note the US_MD2 field (Document type) for these summaries will be “STP”. These summaries should be in MS Word file format (see item 6 under Dossier formatted submissions below).
8. If the study summary is a summary of multiple studies (one-to-many) then they may require their own MRID (see item 5 under Dossier formatted submissions below). They should be submitted as PDF files. If there is a desire to submit MS Word versions of these summaries (please consult with the appropriate regulatory for guidance on this), the MS Word files would be considered “summaries” of the parent study (in this case the PDF version) and should follow the one-to-one summary guidance (see item 7 above and item 6 under Dossier formatted submissions).