Communication to Industry on data reconciliation for Paediatric Decisions in IRIS

As part of the transition of Paediatric procedures to IRIS, EMA has assigned a specific Industry organisation and location to each Paediatric Regulatory Entitlement in IRIS. These correspond to the EMA Decisions granting a PIP (Paediatric Investigation Plan) or a product-specific waiver, or a modification of an existing PIP.
The latest decision on a PIP, that is either the initial one if no modification has been requested or the latest modification of the PIP, and all decisions on product-specific waivers are already visible for the holders, in the IRIS portal section named “Org. Reg. Entitl.”. IRIS Industry users will be able to check which Paediatric regulatory entitlements are assigned to the organisation(s) to which they are affiliated.

In addition, the Excel file attached contains the list of all latest decisions on paediatric regulatory entitlements, with the assigned organisation / location.

Please note that the reconciliation and assignment has not always been possible to the address mentioned in the original EMA decision, for reasons including for example:
 

• The address may not correspond to an existing, active location in OMS (Organisation Management Service, the master data used in IRIS).
• The organization of the holder does not exist anymore in that country, due to closure or merger.
• The name of the organization in the original application and decision may not correspond sufficiently to that stored in OMS and IRIS.
• The application and decision were in the name of an individual, who does not have an IRIS contact or has moved to a different organization.

Every effort has been made to assign each Regulatory entitlement to the closest possible organization of the same global group, including occasionally in a different country. However, for 31 active Paediatric Regulatory entitlements (PIP or Waiver granted), no assignment has been possible and therefore the records are still assigned to “European Medicines Agency".

Holders of PIP/waiver decisions are invited to check the attached list, including decisions still assigned to EMA; should they wish to transfer a Paediatric Regulatory Entitlement (PIP/waiver decision) to another location of the same or a different organisation, the procedure can be done directly in IRIS, using the the process type “transfer of PIP or waiver”. This process type allows a current holder of a Paediatric Regulatory Entitlement to directly transfer an entitlement to a different location of a same or another organization, via a self-service process in IRIS. Note that Regulatory entitlements, including PIPs and product-specific waivers, should be assigned to the location corresponding to the legal seat of an organisation. 

In case of problems, please raise an incident in the EMA ServiceNow platform (use “Reassignment of Paediatric Regulatory entitlement(s) in IRIS” as the subject of the request, to facilitate routing).

Finally, please note that for each Regulatory entitlement the contact person from the applicant and the email for interested parties have been added to the records. It is possible for holder to edit these data directly in the IRIS portal, and to add a telephone number for interested parties, simply by clicking on each blue Entitlement Number (decision number) in the tab “Org. Reg. Entitl.”.  

EMA plans to publish Paediatric Regulatory Entitlements, including the email and telephone number for interested parties (but not the contact person), in a future Register in the IRIS portal, like the existing one on orphan designations.
 

How often is this attached list updated?

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. 

Will the entitlement number change after the submission of a first PIP modification through IRIS?

No, regulatory entitlement numbers will not change once assigned after the agreement of the initial Paediatric Investigation Plan. 

how is it possible to download a PIP decision from IRIS?