• RE: Follow up Scientific Advice - Reference to previous Scientific Advice

    This situation usually occurs when the Initial Scientific advice of reference (Regulatory Entitlement) was given to a different Organization (legal entity in a country, for example Initial advice given to ACME France, but now ACME Germany is requesting the follow up), or even to a different Location of the same organization (e.g. initial advice given to ACME France, Paris, but follow up being requested on behalf of ACME France, Lyon).  This is a general rule of IRIS: currently only Regulatory Entitlements and RPIs assigned to the same Location are visible when creating a submission on behalf of a specific location.

    There are two workarounds for Scientific Advice:
    1. If the initial Scientific Advice was granted to another Organization: the initial Organization can transfer the Scientific Advice Regulatory Entitlement to the new Organization. This is done in IRIS with a specific, automated process.
    2. If the initial Scientific Advice was granted to another Location of the same Organization: c​​​​​​reate the submission on behalf of the same Location of the Initial Scientific Advice. (workaround 1 could also be applied here). 
    Of note, we are working to remove the issues caused by the second situation, by making visible all Regulatory Entitlements (Orphan designations, Initial Scientific Advice letters, etc.) and RPIs associated to a given Organization, regardless of the Location, but this is not yet in production. 
    If the workarounds above do not solve your issue, please send a ServiceDesk ticket with the specific details of the Scientific Advice procedure in question. 
  • RE: Orphan annual report submission

    It is likely that there is a problem with the permissions of your account. Please raise a Servicedesk ticket for this, providing the name of your account, and the organization on behalf of which you are attempting to create a submission. 
  • RE: SA request submission by co-development partner

    Your understanding is indeed correct!
  • IRIS release 2.2 in production on 23/11/2020

    • New process type: “Transfer Scientific Advice”. Owners of Scientific Advice Regulatory Entitlements (Letters of Advice) are now able to transfer them automatically to another owner, similarly to the RPI transfer process. Only scientific advice entitlements can be transferred with this new automated process, which is necessary when the applicant for a follow-up scientific advice or protocol assistance is not the same of the initial advice. No fee is charged.
    • New process type: Reassignment of notices for parallel distribution”. This new type of bulk change procedure is now available for Parallel Distribution. The procedure allows reassigning all notices for parallel distribution held by an applicant to a new owner, where as a result of a merger/acquisition the parallel distributor is dissolved, or the legal form has changed.  Applicants are invited to consult the updated FAQ and User guide for Parallel Distribution for more information. 
    • Applicants have to add at least one therapeutic area (top level MedDRA term / SOC) when requesting a new RPI.
    • The Regulatory Entitlements section in the Industry portal now shows the Entitlement Status (active, expired, withdrawn, etc.)
  • RE: SA request submission by co-development partner

    Your understanding is correct. A EMA user affiliated to an Organization can see all the RPIs "owned" by that organization, and all Regulatory Entitlements assigned to that Organization. This is necessary to allow the person to submit applications that require reference to an existing RPI or an existing Regulatory Entitlement belonging to that organization. 

    It is not possible to grant selective access to RPIs "owned" by an organization. The only strategy in this case would be to transfer the RPI temporarily to Company B, which then would be the applicant and would receive the outcome of the procedure. Once the application is submitted, the RPI can be transferred back to Company A (or to a third company).

    Multiple parallel procedures with same RPI, but from different applicants, should be possible in IRIS. 

    RPI transfers can be performed by the current "owner" directly in IRIS, and the procedure is completely automated. 

  • RE: SA request submission by co-development partner

    If person X working for Company B, which does not "own" the RPI since Company A does, wants to create a submission for that RPI and be the portal contact for the submission, then person X can ask an IRIS Industry Manager role to Company A (owning the RPI). In this way, person X will be the portal contact, the RPI will remain assigned to Company A, and the outcome of the SA will be in the name of Company A.
  • Clarifications on the "IRIS Individual user" role

    An "IRIS Individual user" role is not affiliated to any organization, and is intended for EMA account holders who intend to create submissions in their own name, rather than on behalf of an Organization. The "IRIS Individual user" role is therefore granted automatically by the EMA Account management system when requested. An "IRIS Individual User" cannot visualize the submissions, RPI or Regulatory Entitlements associated with any Organization, unless of course the same person also has other IRIS roles, affiliated to an organization. 
  • RE: Submitting annual report in orphan designation

    Yes. The "submission form" is just a copy of some of the data provided to EMA. The previous PDF form is not necessary anymore. 
  • RE: Non-EU based consultants

    In response to your questions:
    1. Your understanding is correct, but in this case for EMA the Applicant IS the Consultant. Any advice will be addressed to the consultant as the applicant. For Scientific Advice this is not a problem for EMA, but for other procedures it may lead to undesired consequences: for example, in the case of on application for orphan designation, the designation would be granted to the consultant, not the (real) "owner" of the product.
    2. Possibility 2 is in fact a variant of case n. two in our initial answer, not case number one. A legal organization in OMS can authorize any IAM User to be IRIS User Admin for the organization, even if that user is not an employee or representative of the organization itself. While this is technically possible, if approved by the organization, it has the potential to create undesirable consequences for the organization itself, of which they need to be aware and accept full responsibility. 
    3. An IAM user can apply as in individual, rather than on behalf of an organization. This is built-in in IRIS. To do so, the IAM user needs to have the IRIS Individual User role, to be requested separately. In this case, the applicant is the individual, and fees will be charged to that individual. 
  • RE: Technical specification

    Thank you very much for your suggestion. We have plans for doing it, but public release of any documentation requires prior preparation and review before publication. Momentarily our team is engaged implementing new and business prioritized functions and cannot spare capacity for publication work. But we added it to the backlog for later delivery.