Paolo Tomasi EMA

If it is not known whether the submission is to be found in the draft, ongoing or completed section of the IRIS portal, it is possible to search for a submission number in all three sections together, by selecting the "Submissions" tab and then the "Submission" text in the top row (above the line). Unfortunately, it is not possible to provide in the email a URL link to the submission, because the URL is not permanent but changes according to the status of the submission (draft, ongoing or completed). 

The issue has now been addressed as part of the GCP procedure mentioned. Please note that Forum posts are intended for questions on general issues and applicants' discussions, and that no confidential information should be disclosed.
The Forum does not replace the existing communication channels:

• Questions on ongoing procedures at EMA should be submitted as a reply to any email received from IRIS regarding the specific case.
• Use this form to send a request for information from the European Medicines Agency or to make a formal request for access to EMA documents that are not already published on the EMA website. 
• Problems and technical issues about IRIS should be reported to the EMA ServiceNow. If you have difficulties in obtaining a role or affiliation to access IRIS, please select "IRIS account access and management" as the service, in the specific ServiceNow page.

The request for a preparatory meeting is done within the application for Scientific Advice, in the "procedural information" section. See attached screenshot. 

Processing of marketing status submissions is automatic, and therefore it is not possible to withdraw a submission, once this is completed, submitted and validated by the system. Of course, it is possible to create a new submission to reflect the new situation; this will overwrite the data stored for the individual presentations in each member state. 

A final decision has still to be made on this issue, however it is likely that for submissions sent before 4 Jun the current (non-IRIS) process will apply, for validation and the initial assessment. Special arrangements may prove indicated for applications for initial Paediatric Investigation Plans, if a Request for Modifications is issued. Please check the What's New in IRIS forum regularly, closer to the go-live of IRIS for Paediatrics, for updated information. 

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.

GCP Inspections are run on an Authorization Medicinal product, not on an RPI, so the status and the ownership of the RPI is irrelevant and may be different from that of the Authorization product. As such, it cannot be the cause of your problem. Please note, however, that you can only add managers or contributors among IRIS Industry Portal Users who are affiliated (also) to the company which is the applicant/MAH for the Authorization Product, for reasons of confidentiality. 

It is indeed possible to apply for orphan designation without a rINN, but the preferred term of the substance involved must be sufficiently descriptive, and as such a company code is not sufficient. Please follow the recommendations of the EMA Substance names best practice document, and proceed to request a modification of the substance name in SMS. This will automatically update the name of your RPI in IRIS, which will allow validation of the submission for orphan designation.
 

Please consult the specific EMA page Notifying a change of marketing status | European Medicines Agency (europa.eu). 

Please consult the specific EMA page, Notifying a change of marketing status | European Medicines Agency (europa.eu), which reports the obligations of the Marketing Authorization holders and the procedure to fulfil them.