Questions and answers on Marketing Status reporting submissions

	Question	Response
Data entry	Why do I receive validation error emails for bulk submissions?	A set of validation rules are implemented on the content of the Excel file which you upload in the section ‘Uploaded proposed marketing status’, therefore wrong format of the data triggers validation issues for those fields.  Please follow the IRIS user guide (Section 6), and, in particular refer to the Figure 17 which outlines the acceptable format and values for the fields on which the validation runs.
Data entry	What are the most frequent mistakes for bulk submissions?	•    Date format. Excel will apply local date and time format to the current marketing status file you downloaded. Do not change it. •    ‘Date of Marketing Status Change’ column contains marketing status instead of the date. Please make sure a correct date is entered in this field. •    Country code is not compliant with ISO standard. •    The default status ‘No data provided’ is not replaced with actual marketing status and/or is not deleted from the file. If ‘No data provided’ is kept in the file, column ‘Date of Marketing Status Change’ must be blank.  •     Data input conditions laid for the four marketing statuses are not observed: o    ‘Marketed’ - ‘Date of Marketing Status Change’ is mandatory.  o    ‘Temporarily unavailable’ - ‘Date of Marketing Status Change’, ’Reason of cessation’, ‘Estimated date of Reintroduction’, Does cessation lead to Shortage’ are mandatory.   o    ‘Not marketed’ - ‘Date of Marketing Status Change’, ’Reason of cessation’, Does cessation lead to Shortage’ are mandatory.  o    ‘Never marketed’ – column ‘Date of Marketing Status Change’ must be blank, no other columns need to be populated.
Data entry	What should I do if I receive a validation error email?	When a submission cannot be validated, a validation error email is sent out and the case is closed. You will have to understand the reasons for invalidation and make a new submission. Visit the submission form in My draft submissions in IRIS and check for validation errors in section ‘Upload proposed marketing status’.  Errors in columns F, G, H, I, J or K – IRIS form will refer you to the row with a mistake and an explanation of what needs to be corrected. Correct the data and make a new submission.   Errors in any other columns - there will be no explanation in IRIS. Please review the data using IRIS user guide. If you are not able to find the mistake, please log a Service Desk ticket, attach the Excel file and a print screen of the error.  "EU Number should be associated with Authorised Product" error in the form – please check the EU number, if you are not able to find the mistake, log a Service Desk ticket with a print screen of the error.
Data entry	My submission has not been closed and I did not receive validation error email.	Your Excel file contains errors. Please review the file using IRIS User guide. If you are unable to identify the errors, submit a Service Desk ticket, attach the Excel file and a print screen from 'Upload proposed marketing status' page of the submission form.

Data entry	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.
Data entry	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.
Data entry	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.
Data entry	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.
Data entry	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.
Reporting	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
Reporting	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
Reporting	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
Reporting	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  withdrawnproducts@ema.europa.eu address still mandatory or is IRIS replacing the current shortage notifications process (via withdrawnproducts@ema.europa.eu)?	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.
Cessation	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
Data entry	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.
Withdrawals	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 general	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.
Data entry	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.

 

Thank you for providing this useful Q&A.
I would like to add a question:
How long does it usually take to update the reported marketing dates:
How many days after a Marketing Status Notification, single submission will the date and status be made available in the Marketing Status Report?
How long do we have to wait after a bulk upload?
 

It should only take a few minutes for you to receive confirmation that the change has been successful or there has been an error. Similarly, a successful change should be visible in the Report within minutes.
 

We sucessfully submitted bulk notifications as baselines for already authorised products: completed positively, case closed, no validation errors
Independly from the format of the uploaded table (Excel or csv as stated in the guidance) the markeitng status report has not been updated.
Data are not available in the report nor in a drafted submission.
Therefore, we are not able to submit a 2. notification as recommend to report a change (see 1. question/answer above).
EMA Service Desk was not able to solve this issue.
Could you please advise how to proceed?

 

Hi, I have 2 further concerns please:
1) In regards to excel and ISO codes, this is not resolved. We have noticed that the template that is inserted in the guidance for applicant still reflect Greece with GR instead of EL (as you have mention it above).
2) how is it possible to correct a false entry in IRIS? (e.g a wrong date for cessation in the past ?)
Thanks.

The ISO codes have been updated in the system and Greece should show as EL. For bulk uploads, please use the excel file that is downloaded from the IRIS system directly on “Download Current Marketing Status” once you select the authorized product, when doing a bulk submission. We are updating the guidance to remove the reference to the other template.

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.

For bulk notifications that were closed with no errors, if the marketing status report is not showing the reported data correctly, please create an EMA Servicedesk ticket (incident). They should be able to investigate the case. Please include the case number in your request.

I noticed that the process had been improved:
Bulk notifications with errors are NOT closed, but re-set to draft submission. The error can be corrected and the notification can be re-submitted.
That's great because it is still the same case number!
Unfortunately, we did NOT receive any mail notification for this re-submitted bulk notification. In the submission form all chapters have a green tick.
We created an EMA Servicedesk ticket, the answer is not yet available.
It would be great if you could please provide some guidance concerning this improved process.
 

When a submission is successful, an applicant receives a confirmation of successful submission. If an applicant does not receive such confirmation, they should check in IRIS the status of their submission. However, the system will be further improved in due time, to generate an automated email in case of failure of validation. 

For products authorised before 20 November 2005 (new legislation) and for which the date "20 November 2005" was used for the sunset clause reporting until now (as start date of sunset clause reporting), can we keep this date in Iris for the baseline or do we have to provide the real date of the first placing on the market if it was before 20 November 2005 ?

Additionally, for new products not yet marketed, do we have to delete all the lines with “No data provided” or do we have to keep them?
 

The real date of initial placing in the market should be reported for all products, also for the ones authorized before 20 November 2005.

For products that have never been on the market, a new functionality is being implemented. A reason for cessation "Never marketed" will be included in the list of reasons and should be visible when reporting" Not marketed" in the context of a baseline submission. This is under implementation and should be in production within a few weeks. For now, you could either delete all the lines with "No data provided" in the Excel file or leave them as is, but avoid reporting a status as "Not marketed" while leaving the date blank: doing so would trigger a validation error.

Thank you very much for your response Virginia. We want to share with you that on the basis of the prior responses available in the Forum about the “Marketing status reporting submissions”, we are now using the date of 1.1.1900 for the preparation of the baselines for products authorised before 20 November 2005 and for which the real date of initial placing in the market is unknow because the date "20 November 2005" was used for the submissions of Sunset Clause reporting. Indeed, we understand this situation is an exception allowing the use of the date 1.1.1900.



 

<span style="font-size:11pt"><span style="font-family:Calibri,sans-serif">Could you please confirm whether we will receive:</span></span> <ul> <li><span style="font-size:11pt"><span style="font-family:Calibri,sans-serif">an Acknowledgement of Receipt from the Iris system each time we update a marketing status for a CAP e.g. if we add marketing cessation date(s) or marketing date(s) for one or several presentations of a CAP?</span></span></li> <li><span style="font-size:11pt"><span style="font-family:Calibri,sans-serif">And if an Acknowledgement of Receipt is sent by the Iris system what kind of information this document&nbsp;will provide: the date of the notification in Iris? And/or the presentation(s) for which the marketing status has been updated? And/or the type of marketing status change (marketing cessation or placing on the market) ?</span></span></li> </ul>

Has anyone been successful in processing Marketing Status Notifications, either single or bulk?&nbsp; A number of my colleagues and myself have tried but without success.

Hi Robert,&nbsp;<br> <br> We have made first bulk submission early this week and it is awaiting review by the agency.&nbsp;<br> 

sSwapna Bapatla please note that in the IRIS system I can see only one submission in your name, and it is marked as "Cancelled from Industry" (EMA/PA/0000081147).
As such, you won't receive further notifications.

<a href="https://iris.ema.europa.eu/public/e9393f08-878e-e911-a89e-000d3a265cb7/forum-posts" title="Robert Castelow-Sturges">Robert Castelow-Sturges</a>, there are currently 354 completed submissions for Marketing Status in IRIS. That said, we acknowledge that there are unfortunately a number of bugs in the functionalities for marketing status reporting, which we are currently addressing. Please bear with us while the issues are fixed. You are welcome to report general difficulties in the other Forum (General Discussion and self-help · IRIS (europa.eu)), as this thread is being closed. Also, for specific errors you can raise a <a href="https://servicedesk.ema.europa.eu/jira/servicedesk/customer/portals">Servicedesk </a>request.&nbsp;

dear IRIS colleague;&nbsp;<br> you say "<strong>that for reporting for RoW withdrawal should be done as per the existing process. <em>This functionality may be included in IRIS in the future. </em>And for shortage:&nbsp;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. N<em>ew functionalities may be included in the future</em>."</strong><br> CLARIFICATION QUESTIONS:&nbsp;Do you have an estimation of when the reporting of shortage will be transferred completely in IRIS ? In the mean time, could you please confirm if we should only do the reporting of shortage per current process or if a double reporting is expected in IRIS in parallel of the current process ?<br> <br> thank you very much<br> <br> &nbsp;

Currently there is no expectation for double reporting. The Marketing Status is reported through IRIS just indicating if a shortage is expected yes/no, but the report of the shortage itself needs to be done as per current process. Changes to the shortage reporting process will be communicated to Industry in due time.

Concerning the category of cessation:
"Definitive Marketing Cessation of one/more presentation in one/more member state", we would like to take the opportunity to get your confirmation that this notification by Email could be stopped from 1 May 2022 as we have notified this Definitive Marketing Cessation via EMA IRIS Portal in May 2022.