Ian Hardern Mr.

I am in the process of requesting SA for a product that has just been given MAA by the centralised procedure to our partner company. The partner company has transferred the RPI to allow my company to request SA.
If I select Yes to the question "Has marketing authorisation been granted already for this product in the EU"  the product in question does not appear in the centralised product drop down list of selectable products. Either this is because the MAA has only just been granted and so hasn't been updated in the system, or because the MOH is our partner company and the drop down box of products is only those for my own company. Could confirm if the centralised products in the drop down box are associated with the company or the RPI? e.g. would I expect to see the newly approved product eventually appear in the list even though the MOH is another company.

If I select No then I can move to the next question "planned date of next regulatory procedure (marketing authorisation/variation/extension)" 
I cannot consider the next date as for "marketing authorisation"  as the product is already authorised to our partner company. I could select a date for our partner company's next proposed variation or extension and class this as a centralised procedure.
 Would this be the route to take even though I have selected No  to the initial question of "Has a marketing authorisation been granted already for this product in the EU?"

Thanks for any direction for filling in these fields you can provide in this circumstance.

Continuing the same thread and thoughts as the last answer provided:

Hopefully one last question regarding the RPI transfer and the  Company B point of contact for the Scientific Advice submission.

Once a Scientific Advice submission has been submitted and Company B transfers the RPI back to Company A, I would just like to confirm that all correspondence associated with the Scientific Advice submission by Company B  will be sent to the Industry Manager of Company B who did the submission, even though the RPI has now transferred back to Company A. I suspect this would be the case, as the contact is associated with the submission and not the RPI, but it would be good to get confirmation of that.

Thanks in advance for your continued assistance. 

Thank you for your confirmation and clarity of response. It's very much appreciated.

Thankyou Paolo for your response.
If I understand your response right  - you are saying that  person X  would ask to be an affiliated IRIS industry manager to Company A.  My understanding of this route is that person X, having been granted affiliation to Company A, would then be able to see all Regulatory Entitlements and Research Product Identifiers for Company A.
If, because of potential confidentiality / legal issues caused by the affiliate (person X) being able to see all of Company A's Regulatory Entitlements and Research Products Identifiers (not just the RPI subject to the collaboration agreement between Company A and Company B), affiliation to Company A as an industry manager is not feasible, how can company B request SA for their CTAs without transferring the RPI?

If an RPI was to be transferred between Company A and Company B multiple times, can both companies have parallel active submissions in the IRIS portal using the same RPI ?
e.g. Company A submits a SA one month, then transfers the RPI to Company B who submits a SA in time for the following months procedure and having done so then transfers the RPI back to Company A, both Companies would have SA procedure on-going that are linked to the same RPI. Would this be allowed / feasible?    
Thanks in advance for any assistance you an provide at this time.
As you can see there are potential issues with submissions through the IRIS portal using the same RPI which is subject to a collaborative agreement between two companies and I am trying to understand what options there currently are for two companies to "share" an RPI for submissions through the portal, without compromising potential confidential information.

If two companies are co-developing a drug and the company that does not have the RPI registration wants to request scientific advice for a clinical trial that they will be sponsor for, how do they go about requesting SA via the IRIS portal without transferring the RPI registration:
Would their development partner, that has the RPI registration be able to submit the SA request and documents of the other company on their behalf and have the point of contact for communication between the EMA and the SA requestor be from the partner company (who don't have the RPI registration).

Thank you for your response, I had thought it might have been to do with it being a folder. But we will reach to our contact in the first instance to ensure the submission has been (temporarily) reopened, just in case that might be the issue. Thanks again for the alternatives to try
 

I want to replace the current reference zip folder in my ODD submission (needed as additional references used in response to validation) with an updated reference zip folder, but am unable to a, delete the original zip folder or b, overwrite the original zip folder. Is there a way  of replacing the original that I am missing or do I just upload an "updated" Bibliography zip folder in addition to the original.