Susanne Hense

Dear Poonam
thank you so much for providing the news concerning GMP Inspections!

I would like to ask a question concerning
"Upon adoption of a GMP inspection request by the CHMP or CVMP, the user will receive a notification from EMA indicating that an inspection request has been adopted by the relevant committee (CHMP or CVMP) for one of their products."

The user is the product responsible person notified to EMA, correct?
Is it a pre-requisite for the notification that this user has already IRIS access or can the user request IRIS access after receipt of the notification per mail?
If the user needs access to IRIS prior to the notification, all responsible persons will request access.
In IRIS there is no relation between user = product responsible person and a product until the GMP inspection process starts, correct?

Kind regards, Susanne
 

Thank you for providing this useful Q&A.
I would like to add a question:
How long does it usually take to update the reported marketing dates:
How many days after a Marketing Status Notification, single submission will the date and status be made available in the Marketing Status Report?
How long do we have to wait after a bulk upload?
 

Dear Poonam
thank you for your advice for baseline submissions!

I need your help for an important date:
If I use "Marketing Status Notification: bulk upload" for baseline submission I cannot enter "Date of intial placing on the market".
Only "Date of Marketing Status change" can be submitted.

"Date of intial placing on the market" is important and a column of the Marketing Status Dashboard download.

How can I provide the "Date of intial placing on the market" in baseline submissions?

Kind regards, Susanne

Dear Poonam Sabharwal
thank you very much for this important news!

Do you have any guidance how to perform baseline submission for already authorised products?
Can you please advise how apply for corrections of products for e.g. under products/marketing status I can see a product for which my company is not the MAH.
​​​​​​​
Many thanks in advance, Susanne
 

IRIS RPIs can be used in paediatric submissions - is this correct?
e.g. in PIP delivery file
Is there any guidance available?
 

Thank you, Paolo!
This is really helpful :-)
KInd regards, Susanne

Dear Paolo,
is there any news available concerning the marketing status reporting e.g. a new go-live date?
Kind regards, Susanne

Dear Paolo
Thank you for clarification!
My understanding is that the maintenance of marketing status will start end of April.
Do you know by when baseline submission will be required?
Which role do I need to submit the status, IRIS Industry General Manager?
Will there be a feature to export the data similar to the download of parallel distribution?
Many thanks in advance, Susanne
 

I would like to suggest to publish under Public registers & lists those RMS lists used in IRIS procedures.
To apply for a change (change request in RMS) I need to know which RMS list is used as pick list in which procedure.

 

Dear Paolo
in addition to the above mentioned requirements for RPIs the therapeutic area (TA) must be selected.
What is the purpose of this attribute on substance level?
One substance can be developed for different therapeutic areas;
The TA selected during RPI request can not be changed during a specific procedure, only additions are possible.
A SA procedure could be for an indication in a therpaeutic area, different from that displayed on RPI.
Why is the system designed to add a TA already on RPI request?
Why is it not possible to delete this TA if not applicable in a specific procedure?
Looking forward for your reply,
kind regards, Susanne