Susanne Hense

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.
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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

Dear Carlotte,
thank you for this information.
May I ask you to provide definitions for these new data fields?
What is a contact for public enquiries in context of Authorised Products or Orphan Drug Designations?
Do you expect us to fill the contacts details retrospectively for all our REs?
In OD procedure the following data fields are available:
"E-mail address for general public enquiries (after designation)" and "Contact number for public enquiries"
Will contact details entered in OD procedure appear in RE in the OD list?
Kind regards, Susanne