• RE: Marketing Status reporting implementation plan and baseline requirements

    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
  • RE: Variations

  • RE: Product name associated to RPI

    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.  
  • RE: RPI request - substances to select keep loading - no progress possible

    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. 
  • RE: Reporting of marketing status - go-live date ?

    We are hoping to put the system online by the end of April. 
  • RE: RMS Lists used in IRIS procedures

    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
  • RE: Q&As on IRIS registration, login and RPI requests

    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.
  • Communication from EMA for IRIS submissions is directed to the "Portal contact" only

    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.

  • RE: IRIS Industry Contributor

    To do what you intend, the consultant would need first to get an affiliation to your organization as an IRIS Industry contributor. If you grant this role, the consultant will indeed be able to see all your RPIs. However, the consultant will not be able to create a new submission, nor withdraw an existing one.