Isha Arora Dr.

At the Industry Stakeholder Platform meeting on the centralised procedure on 23/06/2025, LINK here, Information was shared on on clockstops/restarts for processes implemented in IRIS.
Is this already effective ? When will it be shared more ''officially'' with stakeholders. Will the IRIS guidance documents be updated accordingly, and by when ?
Thank you, Isha 

What is the ''RPI contact person'', why is this requested, for which purpose, and how does it connect or not to a product contact person, and procedure contact person ?
 

Dear All, I would like to follow-up on my previous questions please here above. BR, Isha

In addition,

1. It is not clear how/ from which time point the Contact person authorised for communication between the MAH and the competent authorities (referred to in sections 2.4.3 of the application form) has been assigned - as in some cases old contact person has recieved the EMA reminder email (although change contact form has been submitted previously and acknowledged by EMA) ?
    
2. How those contact persons will be maintained ? change of contact in IRIS is flexible per submission. However, when we want to change a whole product contact person, do we still need to submit the contact change form via Service Now  to EMA ? 
3. How will this person be or not be assigned to all previously related product procedures ?

Thank you.

Hello,

Do the following contact persons also need to be registered in EMA IRIS Portal , as some have already received reminders emails ? (That was actually not announced/ understood previously) ? 
Can we keep the generic emails for those , as there is a higher risk of missing urgent/ legal emails (especially for QPPV and MAH Contact for CD) ?

• Contact person at the MAH address (referred to in section 2.4.1 of the application form)
• Qualified person in the European Economic Area (EEA) for pharmacovigilance (referred to in section 2.4.4 of the application form).
• Scientific service of the MAH in the EEA as referred to in Article 98 of Directive 2001/83/EC (referred to in section 2.4.5 of the application form)
• Contact person in the EEA for product defects and recalls, as defined in Article 79 of Directive 2001/83/EC (referred to in section 2.5.1.1 of the application form)

Thank you.
 

For an upcoming PIP submission in IRIS, the second category is 'Updated Information on RPI' and there are a series of questions on the submission pipeline - please attached screenshot.
Can you please explain how those questions are even related to RPI scientific data in IRIS, and why those questions are displayed as part of a PIP submission ? 
We believe that this a total separate topic (submission predictability information) which should not be part of a PIP submission.
If you can please also clarify how this data is collected, tracked, used and communicated further within different stakeholders?


 

Hi, following my last question, I was wondering if the same could/will be applied for the email for public enquiries for Paediatrics Submissions?
1- Can we maintain that via IRIS as well ?
2- If not, how can we request update of emails displayed on EMA webpages ?
Thanks, Isha 

Thank you for your quick reply. This is very helpful.
We appreciate that the EMA standard website will be updated in a timely manner (as currently there may be some mismatch).
 

Hello,
I have a question in regards to the Public List of Opinions on Orphan Medicinal Product Designation, where the email for public enquiries is visible.
1- How is this email maintained, in IRIS or not ?
2- If correct in above mentioned public list, How is the correct email reflected in related EMA webpage ?
Thanks,
Isha 

In the IRIS guide to registration and RPIs, section 5.4, it states the following:
''Every IRIS Industry Manager or Contributor affiliated to an Organisation can see all Regulatory Entitlements associated to the Organisation (such as Orphan Designations and Scientific Advice outcome).''
Where can we see all SA outcomes for an ORG ? can we also extract/download the list for SA?