Isha Arora Dr.

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?

Hi,
According to IRIS Guide of applicants, "Upon adoption of a GCP inspection, [...] you must update the submission with the necessary information (i.e. Purchase Order (PO) number and requested documents) within 10 working days of the inspection announcement".

1. In regards to PO number, can it be the study sponsor PO number ?
2. Can you confirm it does not have to be the MAH PO number ? (in which case it does not even make sense to ask for it)

I would appreciate your prompt reply please as it could significantly impact the way our internal organisation for fees payment is setup.
Best Regards,
Isha

Hi, I would like to confirm if the deadline of 30-April-2022 for submission of marketing status baselines is still valid, as related EMA tickets have been suspended due to IT improvements/upgrades ongoing in the background.
It's only 9 working days left and it still does not work.
Thanks, Isha