How do I do "baseline" submissions for already authorised products?

For authorised CAPS already marketed in at least one EU/EEA MS, MAHs should progressively upload the marketing status of their CAPs in IRIS during a 6-months transition period (baseline data). To upload the baseline data, the same options available to report marketing status updates can be used, i.e. single or bulk upload. In case of products with multiple presentations, the bulk upload is recommended, but this is at the discretion of the MAH. For detailed information on how to perform the submission, see IRIS technical guidance (sections 6.1 and 6.2).
When submitting the baseline for the first time, the marketing status will appear in IRIS as ‘No data provided’.

•    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.

Example: A CAP where presentations 001 and 002 are currently in the market in ES and PT.  Presentations 001 and 002 were first launched in ES on 01/01/1999 and in PT on the 03/02/1999. The IRIS database reflects: No DATA PROVIDED for all presentations in all EU/EEA MS.
Report for 001 and 002 STATUS: MARKETED. ‘Date of Marketing Status change’ 01/01/1999 for ES and 03/02/1999 for PT. This will result in 01/01/1999 becoming the ‘Date of initial placing in the market’ in ES and 03/02/1999 becoming the ‘Date of initial placing in the market’ in PT.

•    Presentations that have never been marketed in at least one Member State should be kept as ‘No data provided’. This is because it is currently not possible to report “Not Marketed” without a ‘Date of Marketing Status change’. At the end of the 6-month transition period at the latest, the Agency will automatically change the status of all ‘No data provided’ to ‘Not Marketed’. Moving forward, the newly authorised CAPs will be added to IRIS as ‘Not marketed’ by default.

•    Presentations that were previously marketed and for which the MAH would like to report a (temporary or permanent) marketing cessation as the first marketing status report through IRIS, this needs to be done in two steps: the initial placing on the market needs to be reported first before the marketing cessation can be reported.

Example: Presentation 001 of a CAP was first placed in the market in Austria on 01.03.1995 and is permanently ceased from 01.03.2021. The MAH should report as a single or bulk upload a change in Marketing status to ‘Marketed’ with ‘Date of Marketing Status change’ as 01.03.1995. One this case is processed, the MAH should report a change of marketing status as ‘Not Marketed with ‘Date of Marketing Status change’ as 01.03.2021.