Posted Tue, 26 Jan 2021 11:23:33 GMT by 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.
Posted Wed, 27 Jan 2021 16:18:52 GMT by Paolo Tomasi EMA
The list of centralised procedures in the dropbox is filtered by company, not by RPI. Please note that the update of this list is still manual, and there may be several days of delay (up to 3 weeks) before the IRIS list is updated. We plan to do the import every two weeks very soon. If there is an urgent need to make a procedure visible, please contact EMA service desk. 

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