Paolo Tomasi EMA

Please see the answer to Research product data update: "Foreseen date of next MAA for this RPI" when no future MAA is planned · IRIS

The field "foreseen date of the next Marketing Authorisation application submission for this RPI" does NOT cover variations for an existing Marketing authorisation, but only new MAAs, for example a new MAA for an orphan condition when the same RPI already is linked to a "standard" (non-orphan) authorisation product, or when a generic version is developed for an existing "standard" authorisation product. If no new MAA are foreseen for the RPI in the future, then 31/12/2099 should be specified (not 21/12/2099). 
The fields "foreseen legal basis of next MAA" and "foreseen eligibility basis of next MAA" should include the option to select "N/A" for these situations, this is a known bug and it is scheduled to be fixed soon; until then, please select the existing legal basis and eligibility basis. 

Thank you for this question, which offers us the chance to clarify that the behaviour described is in fact by design: applicants can only add new technologies, or therapeutic areas, to RPIs (research products), but not remove them. These attributes apply to the development product in general, and not to a specific application for a given condition. If an applicant has added an enabling technology or therapeutic area by mistake, it is necessary to send a request to remove the attribute, with a declaration that the specific item has not applied and will not apply, in the intention of the applicant, to the global development of the product.

Paediatric procedures: transition to IRIS

Q. Which kind of changes will affect scientific documents in IRIS?

1. The scientific documents template has been simplified (e.g. comment boxes have disappeared) so, even if the concept will remain the same, the template will be slightly different and has been already published in the specific page on the EMA website.

Q. When is it possible to input procedures on the IRIS platform?

1. Submissions for all paediatric procedures must be made in IRIS from 4 June 2024.

Q. Will the old procedures be migrated? When?​

1. Yes, migration of selected data from all previous paediatric procedures has been completed at the present time (October 2024). More importantly, all Paediatric Regulatory Entitlements (PIP or waiver granted) have been already migrated to IRIS, assigned to a LOC-ID of an organization, and are also visible in the public Paediatric Register. For further details, please see also Paediatric Regulatory entitlements in IRIS (Decisions on PIPs and product-specific waivers) · IRIS (europa.eu).

PIP/waiver Regulatory Entitlements
Q. After 4 June 2024, what is the process to notify the following changes:
  a) change of PIP holder of an approved PIP or waiver?
  b) change of applicant address?
  c) change of authorized contact person?
  d) change of contact for public enquiries?
 

1. a) and b): The IRIS platform allows industry users to transfer an existing PIP or Waiver granted to a different organization, or to a different location of the same organization. The process is automated and takes only a few minutes. For example, PIP holders may want to use the feature to assign all their PIP Regulatory Entitlements to the same location, which should normally be the legal seat of the organization.

c and d): The authorized contact person (who is not public) and the contact data for public enquiries (email and phone number) can be changed directly in the IRIS portal by any IRIS Industry user affiliated to the PIP/waiver holder. This is done by editing the regulatory entitlement record.

Q. Is there a requirement that a PIP related to an approved product is held by the same entity as the MAH? Or could it be a different entity of the same group?
 

1. A PIP or Waiver Regulatory Entitlement can be held by a different entity from that applying for or holding the marketing authorization. Please note that the same does not apply for orphan designations.  

Q. When an initial PIP is modified, will the Regulatory Entitlement be modified as well?
A. Yes, in IRIS the (published) Regulatory Entitlements will retain the same number, but will be modified to include relevant changes, such as any new pharmaceutical forms and routes of administration, the type of entitlement (PIP or waiver), date of PIP completion, etc.

Q. Is it possible to search a submission by PIP number in the Industry Portal?
A. Industry users can list draft, ongoing and completed submissions in the Industry portal, for those submissions where they are listed as Industry Managers or Contributors. As before, Industry Global Coordinators can visualize all submissions. In addition, PIP/Waiver Regulatory Entitlements are public and can be searched and exported in the Paediatric Register. While direct searches in the Register can be done by name of active substance, condition, type of entitlement, Sponsor and date of decision, they cannot be done by PIP number. However, it is easy to export the entire list or a subset and perform a searches by PIP/waiver number in Excel.

Q. How will the ongoing PIP submitted before the go live (using previous processes) be handled after 4 June 2024?

1. Submissions sent before 4 June are being managed in the current (non-IRIS) process. However, at the end of the procedure immediately after the EMA Decision the Regulatory Entitlement will be migrated to IRIS, and will be visible in IRIS. Submissions will also be migrated to IRIS, at a later stage, including those withdrawn or not valid.

Q. How will the migration of procedures with clock stops to IRIS be handled, and when will the Regulatory Entitlements be created if the submission is before go-live?
 

1. Most PIP procedures in clock-stop have already been imported into IRIS, and therefore resubmission should be done in IRIS. A number of procedures which went into clock stop after the switch to IRIS have also been imported between June and October 2024. Please check the What's New in IRIS forum regularly, for any updates. 

Q. At the time of PIP/Waiver Decision, will the information in IRIS be in line with the agreed PIP or not?

1. At present, the key elements of the agreed PIP are present only in the PIP Decision/Opinion document, they are not reimported as structured data into IRIS.

Q. How is a stepwise PIP meant to work in the system? ​

1. The stepwise PIP (sPIP) pilot will be managed as described in the available guidance. The submission of a sPIP application will work in IRIS in the same way as the regular PIP application.

Q. Would it be possible to copy an initial PIP procedure as starting point/baseline for modification procedures?​

1. Such functionality is not currently included in the system, because the outcome of the procedure will be a .docx document. However, it is certainly possible for applicants to extract the information from the Decision (which will be made available as .docx rather than PDF) and potentially re-use it in an in-house automation solution to provide data to the IRIS portal.

Q. What should I do when requesting a PIP if the pH value is not applicable?
 

1. A 0 can be entered if the pH value is not applicable. This is also explained in the error message generated if the field is left empty, and in the label of the field.

Other questions

Q. Can a user access the system if (s)he belongs to another organization?

1. Please see the IRIS guide to Registration, Substances and RPIs in the IRIS Guidance page.

Q. Under “Quality”, if “Parenteral” under “General route of category” is selected, the following fields such as “Max dimension of solid”, “Max no. of capsules” are still mandatory even though these doesn’t apply to the Parenteral category, so 0.00 has to be typed to move to the next step. Is it possible to gray out these non-required boxes in situations where they do not apply?
 

1. Currently, this function is not available. If there is no information applicable for a specific field, then it is possible to type “0” or “N/A” to satisfy the validation rule.

Q. Isn’t there a higher workload to enter everything manually in the system (application form and key elements, all as drop down menus, etc.)?

1. The items in the web form are the same as those contained in the previous PDF forms (Part A plus key elements form). In fact, some simplification has been implemented for the details on the quality. As such, the portal web forms are expected to require the same time as the previous PDF forms or even less.

Q. Should the user be able to generate our data as documents for working/archiving, etc. together when we generate the “Application Form” Word document in IRIS?

1. The system offers the same feature already available for other process types, namely the generation of the application form with most of the structured data submitted in the portal. For the studies table of Initial PIP and Modification requests, not all the columns are included in the table of the .docx file generated, due to readability reasons. A user story has already been added to the IRIS backlog (see Is it possible to extract the Key Binding Elements entered in IRIS for a paediatric submission?).

Q. Considering the number of internal stakeholders involved in generating key elements documents, Industry will most likely continue with a shared document for ease of coordination and IRIS access control, and compile data afterwards. It is not clear what the added value for EMA is, as the applicant can also give key elements in a document from the beginning as a .docx file. ​

1. Key elements proposed by Industry should be included in IRIS as structured data because of:​
   1. The key elements are different according to the type of study. This feature is automated in IRIS, while for .docx template it doesn’t apply.​
   2. The IRIS portal automatically specifies mandatory fields where appropriate (e.g., date of initiation and deferral for initiation are only mandated for clinical / non-clinical studies, but not for other study types).​
   3. Validation rules are implemented in the portal, to ensure that all required information is present. This reduces the risk of non-validation, or postponement/delay. ​
   4. The system is future-proofed for a possible further extension to complete management of the studies and key elements as structured data.

Q. Is there a timeframe provided for Industry to verify if the assigned Regulatory Entitlements are correct?
 

1. There is no specified timeline for this verification process. See Paediatric Regulatory entitlements in IRIS (Decisions on PIPs and product-specific waivers) for more information.

Q. How are Art. 46 procedures managed when migrated to IRIS?

1. Art. 46 procedures are not specifically related to the paediatric procedures therefore they have not been migrated to IRIS yet. They will be moved to IRIS together with other centralised procedures.

Q. Are the Class Waiver decisions (subsequently implying a product waiver) meant to be reflected in the listing, either now or later, for completeness? 
 

1. The Class Waiver decision, which is a single one, is included in the Regulatory entitlements list, as you can see in the Excel file attached in the IRIS Forum.

Please Report an issue with IRIS for bugs such as this one, specifying the RPI number and which contact person should be added. 

Problems and technical issues about IRIS should be reported to the EMA ServiceNow.

Resubmissions for PIP applications in clock-stop should be done in IRIS. The vast majority of PIP procedures in clock-stop have been migrated to IRIS, except a few that went in clock-stop after 1 May 2024. The migrated submissions should be visible in the IRIS Industry Portal under "Draft submissions" or "Ongoing submissions". If the submission is visible, it can be edited, completed and resubmitted there, and new documents can be uploaded directly. 

However, as usual in IRIS, procedures are only visible to the portal contact (and any other users associated to the submissions, but for migrated PIP applications there is only the portal contact). If the contact person of the originally submitted PIP has left the company, or does not have IRIS credentials, the submission will not be visible in the IRIS portal. Under these circumstances, applicants should proceed as follows:
 

1. The applicant should ensure that at least one individual is affiliated to the organisation with the role of "IRIS Industry Global Coordinator", as this role allows visualisation of all submissions from an organisation. The role and affiliation can be requested, as usual, in the EMA Account Management System.
    
2. The IRIS Industry Global coordinator should check the "Draft submissions" or "Ongoing submissions" to verify that the submission is present. If so, the Global Coordinator should add one or more new IRIS Industry Managers to the submission as applicable, and then assign the Portal Contact role for the submission to one of them.
    
3. If the submission is still not visible in IRIS to the IRIS Industry Global Coordinator, please Report an issue with IRIS. The request will be forwarded to the Paediatric Medicines Office staff at EMA, who will guide you on further steps. 

The list is not updated, as it is now available in the public access area of the IRIS portal, where you can download it as a CSV file from the Paediatric Register of PIPs and waivers. 

In principle, resubmissions for procedures in clock-stop should also be done in IRIS. The vast majority of cases in clock-stop have been migrated to IRIS and therefore the submission is visible in the IRIS Industry Portal under "Draft submissions" or "Ongoing submissions"; in such cases, the submission can be edited, and new documents can be uploaded directly. This applies for example to one of your submissions that went in clock-stop in October 2023. 

Some procedures that went in clock-stop recently (after 1 May 2024) are still in the process of being imported into IRIS; additionally, it is possible that the contact person (portal contact) needs an update. It is advisable to proceed as follows:
 

1. An IRIS user affiliated to the applicant with the role of IRIS Industry Global coordinator should check the "Draft submissions" or "Ongoing submission" to verify if the submission is present, and in this case add new IRIS Industry Managers to the submission as applicable, and change the Portal Contact if appropriate.
    
2. If the submission is not visible in IRIS, please Report an issue with IRIS, this will be forwarded to the Paediatric Medicines Office at EMA who will inform you of further steps. 

Please submit these questions in the other Forum, General Discussion and self-help · IRIS (europa.eu). This forum is intended only for communications from EMA to IRIS users.