RE: IRIS for Inspections - materials from webinarThe recording of the webinar has been published now, in the IRIS Guidance page: Training recording: EMA IRIS Inspections Industry training on GMP & GCP
RE: IRIS for Inspections - materials from webinarThe recording of the webinar has not been published yet. The email address which will send the automatic notification is always the same, for all IRIS-generated messages, and is indeed EMA-IRIS@id.ema.europa.eu. Please do not use this email address, except when directly replying to an email received by the system (and without changing the subject, which contains a routing token). Any email sent to that address without a token in the subject field cannot be routed to an appropriate case (procedure) and will remain unread.
RE: How to amend assigned information under RPI - ProductsIt is not clear what is meant by DS. In case incorrect information is identified in an RPI, please submit a Servicedesk ticket, with the proposed edit. However, please consider that some of the information associated to RPI in EMA records is not obtained from the applicant, but derived from public databases, such as ADIS Insight (for example, other names of the product). In such cases, the appropriate ADIS Insight URL to be associated to the RPI should be provided in the Servicedesk ticket, or alternatively the correction should be addressed to the ADIS Insight provider.
RE: How to change an IRIS Sponsor ContactYou do not need to contact any office at EMA to change the Submission contact person (the individual receiving communications from the IRIS system regarding all submissions): this can be done directly in IRIS. Visualise the submission, click on the arrow at the rightmost end of the row (the one used to edit a submission), and select "Manage Submission Contact". Kindly note that the new Submission Contact must already be associated to the submission as an Industry manager, so this step may need to be done first (using the same menu).
RE: IRIS for Inspections - really live ?There is no specific Inspections module. Once EMA starts an Inspection process, submissions will be created for applicants / holders of Marketing Authorisation, which are involved in the Inspection. These submissions will appear in the (existing) submission tab of the IRIS Industry Portal. The industry contact person for the product will be notified automatically via email. It is therefore recommended that the product contact person is kept up to date, using the existing procedures (Notifying EMA of changes to contact persons). The Industry contact person for the product needs to have an IRIS Industry Manager role, to access the submission.
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 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. 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.
RE: Proposing an IRIS Platform MapThe EMA Account Management system and IRIS manage different procedures and are systems based on separate technologies. The IRIS homepage and subpages provide a list of the submissions currently managed by the IRIS system and the related technical guidance. The procedural advice for each procedure group remains on the main EMA website, but links are provided. In addition, a subsection of the home page contains the public registers (organisations, substances, parallel distribution notices).
Regarding emails, there are no "official emails" for IRIS. Only direct replies to messages received from the IRIS system, and containing a token at the end of the subject in the format IRIS:0000XXXXXXX, should be sent. The email address above (EMA-IRIS@id.ema.europa.eu) should not be used for communication that is not in direct reply to a message from IRIS, as the system will not be able to route it to the appropriate procedure; the message will thus remain unanswered. Finally, any other email communicated to industry for use during development of new procedures should not be used for other purposes: the normal channels apply, such as EMA ServiceDesk for access and registration requests and for reporting faults, Ask EMA for general questions not related to a specific submission/procedure, and this Forum.
RE: Export List of substances
A specific feature to allow downloading the substance list is currently not implemented in IRIS. This will be possible via the SMS API, once SMS (the master data for the IRIS substance list) is fully included in SPOR. EMA is working on an export of public substance data into a static list (CSV) to be published on the SPOR portal landing page for SMS. This is expected to be in place by end 2021.
The export of the full details of the substance list (Human and Vet) will be possible via the SPOR API in 2022 once security is in place. For more information about SPOR timelines, you can submit an enquiry via Ask EMA.
RE: Single RPI for different development programs by different organisations?An RPI can be transferred any number of times, to allow different organisations to create new submissions using that RPI. More details can be found in the IRIS guide to registration v2.6 (europa.eu) (last three pages, Transfer of RPIs).
RE: Change in Sponsors Primary ContactAt present, this function is not yet available in IRIS. Please inform the Orphan office, so that the correction can be made in IRIS.