Posted Wed, 05 Aug 2020 16:43:16 GMT by Paolo Tomasi EMA

Registration in non-IRIS EMA systems (Account Management, OMS, SMS)

1. General Manager Role in IAM

Question

Is there a Role of “IRIS Industry General manager” who can perform all the activities and see all submissions?

Answer

EMA has created such an IAM role in the background and is planning to implement it soon.

2. Granting access for all Locations in IAM

Question

Can a user with the “IRIS Industry admin” role grant a role for all locations/ORG-IDs at once?

Answer

Yes, this is how IAM works. An Admin grants affiliation to an organization, which includes all locations that belong to the same parent organization (one legal entity = one organization).

3. Granting access to IRIS for scientific procedures

Question

Will the “IRIS Industry User Admin” be responsible for granting affiliation to users, irrespective of whether they want to do Orphan Application or Scientific Advice Application?

Answer

Applications for all scientific procedure in IRIS can be created with the same IAM affiliation role. This includes Orphan drug submissions, Scientific Advice, ITF, and future procedures that will be included in IRIS (including Paediatrics, Centralised procedures, Inspections etc.). However, Parallel Distribution procedures require a different IAM affiliation (see question 4). Of course, the same person can be affiliated to the same organization for both scientific procedures and Parallel Distribution procedures, if desired.

4. IAM Role needed for submitting Parallel distribution applications in IRIS

Question

Which affiliation role is needed to submit parallel distribution applications?

Answer

You need to request the “IRIS Parallel Distribution manager” in IAM, with affiliation to your Organization. A separate person with an existing “IRIS Parallel Distribution admin” role in your Organization will have to authorize your affiliation. See also question 5.

5. Substances availability in public domain

Question

Is the list of substances publicly available?

Answer

Yes, IRIS includes the all SMS substances that are “approved” and “current”. Only these substances are suitable for inclusion in an RPI. The full, searchable list is available here: https://iris.ema.europa.eu/substances/ . If you cannot find a substance in IRIS, but you believe it to be present in SMS/EUTCT, it probably means that the substance is marked as a “development” substance in SMS, and thus not imported in IRIS; in such cases, please request registration of the substance in SMS as if it were new.  Please note that substances and RPI are different lists (see question 6).

IRIS login

6. Login Process to IRIS – home page

Question

After affiliation has been granted in IAM, login to IRIS can be confusing: an initial Microsoft login field is then followed by a regular looking EMA login page. Having to type in the “@id.ema.europa.eu” is also a hurdle. Can this be simplified?

Answer

IRIS is based on Microsoft Dynamics and Azure technology, where the two systems interact in the cloud. As such, EMA has limited control over the general interface. However, we are working on adding the EMA logo instead of the Microsoft one to make the user experience more coherent.

7. Login Process to IRIS – prefilled fields

Question

Is there any way to simplify login, by having credentials saved/prefilled?

Answer

Pre-filling the username is not possible directly, but one way to mitigate this is to allow the browser to remember the credentials, so that next time the page is open it is pre-filled with the username. This is equivalent to pre-filling.

This is a general function of all modern browsers (e.g.  Chrome, Firefox or Internet Explorer or Edge).

The link below can help you to address this issue:

https://pureinfotech.com/add-new-user-profiles-google-chrome/

Research Product Identifiers (RPI)

 

8. Enabling Technologies

Question

What is the meaning of “Enabling Technology”? Why is this information needed?

Answer

Possible innovative aspects on the development of the product (RPI) are tracked using this list, to ensure involvement of specific expertise as required and to allow forecasting and planning.

9. Mechanism of Action - additional information

Question

Why is a “mechanism of action” (MoA) field included in the Scientific Advice electronic form? This information may not be fully known, especially for very early advice. Will this information be made publicly available?

Answer

The field is not mandatory, therefore if the applicant does not have information to provide, in addition to that available from public sources (which will be displayed in read-only), it is possible to leave the field empty. It is in the interest of the applicant to provide as much information as available, to allow the SAWP/CHMP to provide targeted advice or a correct Opinion. Any additional information on the mechanism of action, provided by the applicant, will not be made public by EMA.

10.Requesting RPI’s in advance

Question

We may have several scientific advice procedures planned for Q3/Q4 this year. Is it possible to already start preparations for requesting RPIs? i.e. before the IRIS system goes live for Scientific Advice submissions.

Answer

Yes, it is possible.

11.No SLA for generation of RPI of new Active substance but can be requested in advance

Question

Can an RPI for a new product be done within 2 working days, to prevent delaying  submissions?

Answer

There is no SLA for RPIs. If one is agreed, it could be like the SLA for the addition of substances in SMS (a different process). In almost all cases so far, RPIs has been granted within 2 working days. Of course, this also depends on the reactivity of the applicants to answer any questions in those rare cases where communication is required. The best way to avoid delaying a submission remains to register any new substance and request an RPI well in advance of the submission of an application to EMA; this can be done months in advance (see

12.Need of an RPI in a Qualification procedure

Question

Is an RPI needed for a Qualification procedure? (Advice or Opinion)

Answer

Yes. See also Question 13.

13.RPIs for non-medicinal products

Question

For a scientific advice or qualification advice/opinion procedure of a novel methodology (such as qualification of a novel endpoint supported by a digital tool) which is not linked to any substance, how can we obtain a new RPI? Should we proceed through the IRIS portal,  or through the former submission process as described in the "Qualification of novel methodologies for drug development: guidance to applicants" (e.g. via qualification@ema.europa.eu)?

Answer

Qualification submissions will be handled through IRIS, but they still require an RPI. For non-medicinal products, however there is a different procedure, as the RPI cannot be requested via IRIS. Please contact the Scientific Advice office directly, at ScientificAdvice@ema.europa.eu

14.Availability of RPI list to everyone

Question

Once an RPI is requested for a new active substance(s), will it appear within the substance list accessible to everyone via IRIS homepage?

Answer

RPIs and substances belong to two separate lists. While RPIs are linked to a specific organization or individual, substances are not. Furthermore, an RPI for a product may include more than one active substance and is intended to track a development entity rather than just the concatenation of the active substances. At present, RPIs are not publicly available in IRIS and each organization only sees the RPIs assigned to it; this may change in the future.

15.Automatic RPI creation

Question

When asking for an RPI in IRIS, why is it not possible to simply fill in the active substance(s) details in IRIS during the intended application, and then an RPI is automatically created in the system?

Answer

This is not possible because the two are separate processes, with separate management at EMA. Substances are mastered in SPOR, they are not assigned to an applicant, and are all public.

As detailed in Question 6, RPIs are permanent and do not change across the lifecycle of a (candidate) medicinal product. Therefore, a new RPI should not be requested if one already exists. 

ADDITIONAL QUESTIONS ON RPI

  • 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.
Posted Fri, 25 Sep 2020 08:31:12 GMT by Paolo Tomasi EMA
Please also find here the presentation given at the web training on 24 September 2020
Posted Wed, 14 Oct 2020 10:39:57 GMT by Isha Arora Dr.
In regards to Q&A 1, IRIS Industry General Manager role,
  • Where do we stand with this ?
  • Will this role be assigned to individuals only (as today with other roles) or will it be possible to register a generic email address for that role ? 
Posted Wed, 14 Oct 2020 12:12:41 GMT by Reicy Brito PhD

To performace a request for scientific procedure (4.2.1 in IRIS guide for applicants V 1.10): In "Choose submission type" appear labelled as "Organisation", "Location" and “Submission Type" (I select the first two on behalf of an organisation), but when I search symbol to look up the submission type : "initial scientific advice-veterinary", this is not available. How I should proceed? Best regards.

Posted Wed, 14 Oct 2020 15:17:08 GMT by Paolo Tomasi EMA
1) yes.
2) you can apply for the correct role and request  affiliation to the appropriate organisation(s) at  https://register.ema.europa.eu 

Best regards
Posted Thu, 04 Mar 2021 12:21:29 GMT by Paolo Tomasi EMA
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.

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