Posted Tue, 30 Nov 2021 09:18:18 GMT by Stephen Mackenzie
I notice in the Marketing Status report, there are a number of fields presented in the report which I don't seem able to actually update via a single submission or a bulk upload.  These are "Date of initial placing on market", as well as the "Future xxx" dates.   I don't see these fields as being available for updating in the single submission form for marketing status or in the bulk upload file which is downloaded?
If we are working to collect this data internally prior to submission, we don't want to ask the business for data points we seem to have no way of updating in IRIS.  But then we don't want to not collect the data, and then IRIS changes and these data points become available in the tool.
Any advice appreciated.
Posted Wed, 01 Dec 2021 16:35:02 GMT by Virginia Rojo Guerra
When a presentation is reported as Marketed for the first time in a MS, the Date of marketing status change becomes the Date of initial placing in the market. This is explained in the regulatory guidance Notifying a change of marketing status | European Medicines Agency (europa.eu) question 6: Presentations of a CAP already on the market: status should be reported as ‘Marketed’ with the date of the initial placing in the market as ‘Date of Marketing Status change’. This will become the ‘Date of initial placing in the market’ once the submission is processed.

This date will remain fixed and subsequent changes in the marketing status won't change this initial date. This is why is important that for products that have the status as No data provided, the baseline should be an initial reporting as 'Marketed' to include the Date of first placing in the market. This date should be the date of launch of that presentation in the MS.  After this first reporting, the MAH can report the cessation with the future date.

If you report a cessation with a date in the future, the fields for future dates will be visible in the Report. This allows to see the current and future marketing status and make searches for future dates.
Posted Thu, 02 Dec 2021 12:08:21 GMT by Stephen Mackenzie
Thanks for getting back to me, although I am a bit confused about the data model at the IRIS end.  Is there only one record per presentation in a market, or are you storing multiple records - one showing the current status and a separate record showing the future position?  Or is it one record, and it just so happens that if a future date is entered - you place these into the future fields on our behalf based on the fact the date is in the future?

What happens when the future date elapses?  Do they suddenty not appear in the future date fields, but because that date has elapsed, they are presented as the current state?
Posted Fri, 03 Dec 2021 14:04:37 GMT by Virginia Rojo Guerra
The current Marketing status is always visible. When reporting future dates, both the current status and the future one are visible. When a date in the future is reached, it becomes the current status and the future dates are emptied. This is to allow for visibility on current and future marketing status. The report allows to search for the situation in the market at a future timepoint, so National Competent Authorities can have visibility of planned changes.

As an example, if I have reported that presentation 001 is marketed in Austria and then I report a cessation by 10th Dec, I will be able to see both until the 10th of Dec. On that day, the status will change to Not marketed and the columns showing future cessations will be empty.

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