Paolo Tomasi EMA

Considering that IRIS is online 24/7 and that in 6 years of operation there have been no significant periods of unavailability, annual statements, signal or other IRIS-based submissions should always be sent via IRIS. 

These are internal codes for the submission category. The current list of category codes is as follows:
 

Submission category	Prefix
General	EMA/GE/
i-SPOC	EMA/iSPOC
Marketing status	EMA/PA/
Parallel Distribution	EMA/PD/
PRIME	EMA/PR/
Product Management	EMA/PM/
Expamed	EMA/EX/
Marketing Authorisation	EMA/VR/
Inspections	EMA/IN/
Scientific Advice	EMA/SA/
Orphan Designation	EMA/OD/
Paediatric procedures	EMA/PE/
ITF	EMA/IT/
ESMP Submission	EMA/Submission
Veterinary Signal Management	EMA/VS/
EO-SPOC	EMA/EOSPOC

As mentioned, it is only possible to delete a document if the application (submission) is in "draft" status, i.e. it has not been submitted to EMA yet. After the application has been submitted for the first time, files cannot be deleted anymore, and the dropdown button will not be visible, even if the submission has been reopened "for edit and upload or "for upload" only. In the case that your submission has never been submitted but still you cannot delete documents, please Report an issue with IRIS  with our service desk, attaching screenshots and including the number of the submission. 

An RPI name is the concatenation of the preferred terms for each substance contained in the RPI, in alphabetical order. To change the name of an RPI it is necessary to update the name of the concerned substance(s) in SMS. You can update the name by providing the necessary information, including the substance ID, in this form: Request SMS services.
Once the substance name is updated in SMS, the RPI name will change automatically. If there is any ongoing case associated to the RPI, before the Opinion, the name of the product in the case will also change automatically, and this will be reflected in the Regulatory entitlement created or modified (if any). 

For a fixed-dose combination (FDC) product, the RPI should be asked in the normal way, in the IRIS portal, simply adding two or more SMS substances in the submission request. "Special RPIs" are not intended for FDCs, they are intended to model situations in which an applicant is requesting an ITF briefing meeting, scientific advice or biomarker qualification procedure in instances where the request is not for a single medicinal product (single substance or FDC), but rather for a methodology, technology, or (for ITF) an initial pipeline of multiple substances/products where it is not known yet which one will be developed. 

Apologies for the misunderstanding. I have asked the Servicedesk colleagues to have another look at your incident, with a view to forwarding it to the appropriate Department. 

Yes. A fixed dose combination product is a different product from any of its components. 

If you are able to create a draft submission for a specific Location of your organisation, and see the RPI, you should appear in the popup menu that allows the selection of a different contact. If this is not the case, please raise an incident in ServiceNow, providing details about the submission number of your draft and the RPI number. There have been a few instances where an Industry Manager was not affiliated to all locations of the same parent organisation, due to a bug. 

Your understanding is correct. The portal and the guidance will be updated to spell out the abbreviation, so that it is  clearer.

The IRIS portal can be used to upload documents into IRIS whenever a submission is "open for edit" or "open to upload". For post-authorisation submission, at present the initial upload of documents remains via the Gateway and Repository.