Paolo Tomasi EMA

As a general rule, once an application in IRIS is submitted to EMA for the first time, it becomes locked and it is not possible to edit the data in the portal or upload new documents. EMA staff can reopen the submission, thus allowing the applicant to edit data and upload new documents (before validation) or to upload new documents only (after validation).
For additional information on a specific application, please reply to an email regarding that procedure, received from the IRIS system. Your reply email will be automatically routed to the appropriate EMA office. 

User Acceptance Testing of the Marketing Status component of IRIS is currently ongoing, and there is a tentative go-live date of end of May. 

A revised version of the "IRIS Guide to Registration" (including information on RPI principles and transfers) has been published on the IRIS Guidance and Support page. 
 

No. 

Your understanding is correct: an RPI is intended for a single medicinal product/development, including fixed-dose combination products (FDCs). It is thus possible in IRIS to select more than one SMS substance when requesting a new RPI.
However, for separate products to be co-administered, or for so-called combination packs, separate RPIs should be requested.
There is no need for the requester to provide a "product name" to relate to the requested RPI: the name of the RPI is simply the name of the active substance, or the concatenation of the active substances in alphabetical order (if more than one). 
Finally, there are currently no plans to make the list of EMA RPIs public.  

The issue may be caused by a local setup problem - you may wish to check whether using a different computer and/or browser and/or network solves the issue. There have been cases where using Chrome instead of Safari has sorted the problem. 
Otherwise, the way to proceed is indeed to report the issue via a Servicedesk ticket. 

We are hoping to put the system online by the end of April. 

These are RMS lists used currently in IRIS, or which will be added shortly. In IRIS, all RMS lists are imported in a single data table, so additonal lists may be added with new releases of the tool (which normally occur every two weeks). Please note that the lists with the shorter number (9 digits  only) are IRIS-only and not present in RMS. 
 

Name	List Id
Age Range	100000000001
Anatomical Therapeutic Chemical classification system - Human	100000093533
Anatomical Therapeutic Chemical classification system - Veterinary	100000116677
Clinical Trial Design Elements	200000014686
Clinical Trial Inspection Outcome	100000075860
Clinical Trial Inspection Scope	100000075861
Clinical Trial Inspection Status	100000075862
Clinical Trial Methodology Elements	200000014631
Comparator Type	100000075863
Domain	100000000004
Dosage Form Term Type	100000073350
Eligibility for Centralised Procedure	100000116083
Enabling technologies	200000003244
Marketing Authorisation Application Legal Basis	100000116045
Medical Dictionary For Regulatory Activities	100000000006
Medicine Profile	200000003186
Nature of the Active Substance	200000003243
Non-Clinical Development Areas	200000014632
Organisation Role Type	220000000031
Pharmaceutical Dose Form	200000000004
Post-Authorisation Safety Study (PASS) category	123456789
Qualification Procedure - Context Biomarker	223456789
Qualification Procedure - Purpose Biomarker	223456788
Qualification Procedure - Questions Biomarker	223456787
Qualification Procedure - Type Biomarker	223456786
Quality Development Scientific Advice Topics	200000014608
Routes and Methods of Administration	100000073345
Scientific Advice - Consent to exchange documents	1000001555521
Scientific Advice Source	100000075871
Scope	100000072055
Scopes of Advice - Clinical	123456786
Scopes of Advice - Non-Clinical	123456787
Scopes of Advice - Quality	123456788
Submission Mode	100000155553
Substance Type	100000075826
Target Species	100000108853
Trial Categorisation	100000116653
Trial Design	100000075934
Trial Phase	100000075935
Trial Scope	100000075936
Trial Subjects Group	100000075937
Variation Classification	100000152091
Veterinary Dictionary For Drug Regulatory Activities	100000111593

New Q&A on RPIs added: 

• An RPI has been assigned for one active substance to a company ("Company A"). This organisation does now reassign this RPI to another company ("Company B"). What is the consequence of this reassignment for Company A? I assume that both companies can use this RPI in parallel. Is this correct?
  No, only company B can now use the RPI. 
   
• Or does this mean that this RPI can be thereafter only be used by Company B and no longer by Company A? 
  Indeed,  but company B can reassign back to company A at any time (including during a submission done by company B using the RPI, after it has been chosen and associated to the submission)
   
• In consequence, that this "reassignment" is essentially a transfer.
  Indeed, that's why the process is called "transfer of RPI". 
   
• Would is be possible that for an "old" and well-known active substance two companies assign RPI individually, i.e. that different RPI exist thereafter for the same active?
  Yes, this is in fact the rule for off-patent products: separate RPIs for generic products. An RPI tracks a development programme, essentially, rather than a specific substance or fixed-dose combination. As a consequence, if the same (off-patent) substance is developed independently, this is reflected in different RPIs. At the same time, the same development programme for a (normally patented) product would maintain the same RPI, regardless of transfers of the product to a different developer, mergers, use of consultants, etc.

The communication model for IRIS is that while there can be any number of Industry managers and Industry contributors associated to a single submission, only one of them is the "submission contact", also called the "portal contact" i.e. the primary contact person to whom all communication is sent (by default) for a given submission. The default "submission contact" is the Industry manager who submits the application. 

The "submission contact" role can be reassigned at any moment, and repeatedly, by any of the Industry managers associated to a draft or ongoing submission (but not for completed submissions). EMA users of the IRIS system will send communications only to the "submission contact", by default. This is for efficiency and security reasons. 

Applicants can nominate additional Industry managers,  and reassign the "submission contact" role as required, for example before a period of leave of the "submission contact". This can be done in IRIS, for draft or ongoing submissions, by clicking on the V to the right of the submission, and selecting "Manage submission contact". 

In addition, applicants may also wish to set up appropriate auto-forwarding rules in the email system of the "submission contact". 

IRIS is being built to allow applicants to self-manage their "submission contact" role for each draft or ongoing submission. In future, EMA plans to extend this concept  to self-management of the contact person and contact data for interested parties assigned to Regulatory Entitlement, and potentially also for Authorisation Products. Changes will be made by sponsor/marketing authorisation holders directly in the IRIS Industry portal.