Stephen Mackenzie

Hi, So the 11 we see in IRIS now is not the final 11 we will see when making an IRIS submission for a single or bulk upload of a marketing status?

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

 

I am confused by the guidance, as there are actually 11 reasons for cessation available when creating a draft IRIS submission.

Hi,

In the guidance there are 8 reasons for cessation but when creating a draft submission in IRIS there are 11.  We have built our own internal data collection processes around the 11 items in IRIS, as this would make sense to us to mirror IRIS.

Is it 8 or 11, if 8 why are 11 presented in IRIS?  I see in some other responses on the forum you are advising people of 8 reasons for cessation but IRIS itself presents 11, including "down prioritisation due to Covid-19" and "Other" not listed in the guidance.

Regards

Stephen

A question was raised internally about how to manage things like flu vaccines which are seasonal.  Usually these are only manufactured at specific time periods, and then the shelf life is very short (for example 6 weeks), so supply naturally runs out in Jan\Feb\March.  This isnt really a supply shortage or a cessation, it is just the natural ebb and flow of a seasonal product.
 

Why cant we do a bulk upload of more than one authorised product at a time? 

To perform the bulk upload we need to download the bulk upload file, and then we will need to perform a cross reference of our own internal data using lookups.  It would be better if we could do this once, and not have to download 30 separate bulk upload files - one per authorised product - and then perform this cross referencing?

Can we select more than one product, and if not, can this be added as a feature so we can do a real bulk upload of the portfolio, especially important for the initial IRIS submission.
 

We have products we never launched for various reasons in some markets.  However, when I try to create a submission it forces me to enter a marketing status change date (see screenshot).  What date am I expected to enter here for a product which never launched in that market?  Seems that this should be an optional date, or at least optional if certain other options are met like a commercial reason for cessation?

Note I am just creating draft submissions at the moment to test IRIS, so the screenshot is not a real reflection of that products status.
 

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?

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.