Posted Thu, 09 Dec 2021 10:10:38 GMT by Stephen Mackenzie

Hi,

From prior responses on this forum, I understand when we first submit a product as "marketed", the marketing status change date will get mapped to the "date of first placing on the market".  However, what if our very first entry into IRIS, is a notification of a future cessation, and the marketing status change date is a future date to comply with 60 days.  i.e. it is marketed, but our first submission isn't that it is marketed, but that we are communicating a future change.

This means this submission in IRIS never results in a "initial placing on the market" date being available to IRIS.

The whole process would be much simpler if you just asked separately for the date something was first placed on the market, rather than by making assumptions on the marketing status change date, which has multiple meanings over the term of a product in IRIS.

If my first submission to IRIS for a product, is for a marketed product - but the internal data collected was that it is a future cessation, then what happens at the IRIS end, I assume you never receive a "date of first market placement" date for that product?

Do we somehow have to architect our first bulk upload around the nuances of IRIS and how it transfers "marketing status date" to the "date of first placing on the market" for the first submission? i.e. if we have data for our first submission to IRIS of a future cessation, we need to do a dummy first submission to get the product recorded as an on market product first?

Regards

Stephen

 

Posted Thu, 09 Dec 2021 16:03:57 GMT by Virginia Rojo Guerra
The first time you upload a product, the first reported status should be Marketed with the date of initial placing in the market. Is not a dummy submission, but reflecting the current status. Afterwards, you could report the future cessation. This will only happen now during the baseline submission and is explained in the regulatory guidance Notifying a change of marketing status | European Medicines Agency (europa.eu). Moving forward, all new products are uploaded in IRIS with the status Not Marketed, so the first report will always be the first placing in the market.

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