|How to report the Marketing Status of presentations that have never been on the market
|A specific Marketing Status category has been added for products that have never been on the market. ‘Never marketed’ should be chosen from the list of Marketing Status options. Reason for Cessation and the Date of Marketing Status change can be left blank since they will not be mandatory fields when this option is chosen. Newly authorized products will be showing in IRIS with the status ‘Never marketed’ by default.
|After uploading the marketing status of the product in line with the guidance there is still no update or change in the marketing status of the product in the Report and it still appears as
‘Data not available’ in the system.
|A bulk submission is validated by the system automatically and the notification should be received within minutes. The new status should be visible immediately after the cases is completed (it may take a few minutes for the system to refresh). If the information is not visible in the Marketing Status Report after an hour of a successful submission, please check the tab My draft submissions in case the submission failed at validation stage. Please check the errors, correct Excel file and re-submit. If the case is in Completed submissions and the data is not visible in the Marketing Status Report, please raise a ticket to EMA Helpdesk.
|Some products and presentations are not available in IRIS
|Product data is regularly fed to IRIS by several systems, therefore if the product is not showing in IRIS after a week of being approved, please contact EMA Help Desk indicating the name and product number and the MAH to which is assigned. Some newly approved products/product presentations may still not be available in IRIS.
|Marketing Status Report
| In the Marketing Status report, there are a number of fields presented in the report which do not match with the fields in a single submission or a bulk upload. These are "Date of initial placing on market", as well as the "Future xxx" dates.
How can these fields be updated?
|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 (https://www.ema.europa.eu/en/human-regulatory/post-authorisation/notifying-change-marketing-status) 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 will not 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 a cessation with a date in the future is reported, the fields for future dates will be visible in the Report. 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 the current status as Marketed and the future status Not Marketed until the 10th of Dec. On that
day, the current status will change to Not marketed and the columns showing future cessations will be empty.
|Challenges with correcting incorrect data. After declaration and submitting the data, do we have an option to edit the data in IRIS either as a Contributor or Owner?
|It is not possible to correct a "false entry". If the wrong date for a cessation has been entered, a new submission, with the correct date, is needed to replace it. If "Date of initial placing in the market" has been wrongly entered, you need to create an EMA ServiceDesk ticket (incident) to address the issue and have the date changed from the back end.
|It is unclear in case of several future updates, how long it takes to process updates and when we can upload the next update? i.e. Do we have to wait for approval before we can upload the next one?
|For sequencial updates impacting the same product, companies should wait for one change to be reflected in the Marketing Status Report in the IRIS system before submitting another update for the same presentation in the same Member State. The system should be updated within a few minutes (less than an hour) if there are no validation errors. If the system is not updated, please check My draft submissions or the Ongoing submissions tab, as your submission may have not passed the validation stage. In this case correct the Excel file and make a new submission.
|EMA should clarify that submitting the marketing status in IRIS will suffice and there should be no need to re submit along with PBRER submission
|The current PBRER requirements do not change with the implementation of the Marketing Status report in the IRIS system
|It is not clear if a shortage is declared between 2 dates, whether we are obliged to go back in IRIS and update once the end date has been reached
|When reporting a marketing cessation, MAHs are asked to clarify whether they anticipate a risk of shortage. MAHs should provide such information to the best of their knowledge at time of reporting a marketing cessation. This information will not replace existing processes to report shortages to EMA . This is only intended to facilitate dissemination of the information within EMA and EU Network
|What are the expectations on how quickly to update IRIS when the marketing status changes?
|The timelines for the marketing status notifications have not changed with the introduction of the IRIS platform for Marketing Status. Please see question 5 in Notifying a change in Marketing Status https://www.ema.europa.eu/en/human-regulatory/post-authorisation/notifying-change-marketing-status
| Via IRIS there is an obligation to report if cessations lead to shortage and for temporary cessations it is necessary to report estimated date of reintroduction. Are shortage notifications via the email@example.com address still mandatory or is IRIS replacing the current shortage notifications process (via firstname.lastname@example.org)?
|The current process to report shortages does not change with the introduction of the marketing status reporting through IRIS. The field is included in IRIS for information only to act as an early warning and it does not need to be maintained. It does not replace the need to report shortages via the normal channels. New functionalities may be included in the future.
|Can EMA give an explanation or definition of temporary cessation?
|By analogy to the placing on the market, the “cessation of placing on the market” or “marketing cessation” is defined in the general principles outlined in the Chapter 1 of volume 2A of the Notice to Applicants as the “cessation of release into the distribution chain” with the consequence that the concerned product may no longer be available for the supply to the patients.
The date of marketing cessation shall be the date of the last release into the distribution chain.
This has not changed with the introduction of the marketing status reporting through IRIS. Please review the information on the link below: https://www.ema.europa.eu/en/human-regulatory/post-authorisation/notifying-change-marketing-status
|It is not clear how the data entered in IRIS should be approved. IRIS does not give an approval option in the portal
|There is no separate step for approval of the data. When submitting the data in the system, applicants are asked to tick a declaration, which is a confirmation that the data is correct.
Every company has different internal processes that should be managed outside the IRIS platform.
|Will the report to EMA for the RoW withdrawal due to efficacy/quality/safety be done via IRIS or via the current form?
|Reporting for RoW withdrawal should be done as per the existing process. This functionality may be included in IRIS in the future.
|IRIS does not work properly while using Internet Explorer (I can log in, but some features such as „Submissions“ tab can not be listed) while works ok when using Chrome. Can EMA confirm if Internet Explorer should not be used for IRIS platform?
|IRIS can be accessed on any modern Web Browser, including but not limited to Google Chrome (latest version), Internet Explorer 11 and above, Edge (including the new, Chromium-based Edge), Safari 12 and above, Firefox (latest version), Vivaldi, etc.
|If there is a presentation already in the market for which the company has no record on the date of initial placing in the market in a particular country, which date should be used?
|For Marketed presentations in the MS, MAHs should include the First date of launch of this presentation in the 'Date of Change of Marketing Status'. In the exceptional situation, where this date is not known, MAHs should include the date of 1.1.1900.