Marketing Status is available on IRIS Portal from 26 July 2021

Users can now report the marketing status of centrally authorised medicines (CAPs) in the IRIS platform  from 26 July 2021.
For not yet marketed CAPs, MAHs will have to use the IRIS reporting system for the Marketing status and any subsequent changes in any EU/EEA country.

For already marketed CAPs, the regulatory deadline for MAHs to populate the marketing status of their products in IRIS is six months after launch (i.e. by 31/01/2022). Therefore, it is strongly recommended for companies to start using this new system as early as possible. During this implementing period, the current reporting system via emails and Excel sheets will co-exist with the new IRIS reporting system. 

Three submission types has been made to help user report changes: Marketing Status(Single), Marketing Status Withdrawals and Marketing Status (Bulk Upload)

For more information please check the revised IRIS guide for applicants and the revised Q&A on CAP marketing status updates and withdrawals.
 

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
 

Dear Susanne,
Please find the answers inline

Question1-Do you have any guidance how to perform baseline submission for already authorised products?

We expect that MAHs provide a record for every presentation of a CAP that is currently in the market for every EU/EEE MS.
You can use the Marketing Status (single or bulk) submission for this.
For example, A CAP where presentations 001,002,003 are currently in the market in ES, PT, FR and DE and authorised presentations 004, 005 were never launched in any EU/EEA MS. 
Presentations 001,002,001 were first launched in ES and PT on the same date 01/01/1999, in FR on 01/02/1999 and on DE on 01/03/1999.

The database nor reflects: No DATA PROVIDED FOR all Presentations in all EU/EEA MS of a CAP.

You can report the baseline for this product in 2 ways:

OPTION 1: VIA Change in Mkt status (single):
Change in Mkt status (single): report that 001,002 and 003 STATUS: MARKETED Date of 01/01/1999 in ES and PT 
Change in Mkt status (single): report that 001,002 and 003 STATUS: MARKETED Date of 01/02/1999 in FR 
Change in Mkt status (single): report that 001,002 and 003 STATUS: MARKETED Date of 01/03/1999 in DE
Change in Mkt status (single): report that 001,002 and 003 STATUS: NON MARKETED in the rest of MS.
Change in Mkt status (single): report that 004, 005 STATUS: NON MARKETED in all MS.

OPTION 2: VIA Change in Mkt status (bulk):
You should fill the information as above in the rows of each presentation in each MS.
For 004,005, pls replace the Marketing status from  no data provided to non marketed 

Question 2 : 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.
Any case where you identify a CAP not belonging to your MAH, please report via Service desk(https://servicedesk.ema.europa.eu/jira/servicedesk/customer/portals) by creating a ticket

 

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,

After filled in the EXCEL file with the marketing status of our CAP, the EXCEL list was uploaded but we received following invalidation issues:

Row103:EU Number should be associated with Authorised Product,Marketing Status does not exists,Date of Marketing Status Change does not exists

Row125:EU Number should be associated with Authorised Product,Reason for Cessation does not exists,Does Cessation Lead to shortage does not exists,Date of Marketing Status Change does not exists

Row26:EU Number should be associated with Authorised Product

I followed the guidance to correctly filled in the EXCEl file (e.g. standard terms), I did not change the colu,mns or header!

Please advice how to solve the issues.

Thank you in advance!

KR,
Ben

The fields Date of Marketing status change, Reason for cessation and Does cessation leads to shortages are mandatory fields and cannot be left blank. A new feature is being implemented to allow the reporting of products that have never been on the market. The list of reasons for cessation will be updated to add a new one 'Never marketed' and in this case, the date of marketing status change won't be mandatory. Until this feature is implemented, please do not report presentations that have never been marketed, just remove the rows from the Excel. Otherwise you'll be receiving validation errors. We expect the new feature to be in production within a couple of weeks. If there are any rows showing No data provided, please remove those too and only report the Marketed ones.

On the validation error EU Number should be associated with Authorised Product, it seems to be a recurrent issue we are investigating. Please raise a ticket with EMA Service Desk so the IT team can check what the problem is. Please indicate the case number and provide the excel you are trying to upload.

More info on reporting in the thread: Questions and answers on Marketing Status reporting submissions