Poonam Sabharwal

Please find answers to your questions below:

1. By "User" we mean the Product Contact for the centrally authorised product; this person becomes the Portal Contact (a.k.a. Submission Contact) for the Marketing Authorisation Holder/Applicant in the Inspection procedure.
2. The video recording of the training for Industry held on 10 September will be published shortly on the EMA IRIS website.
3. We are in process of removing the "Guidance for applicants/MAHs involved in GMP inspections coordinated by EMA Version 1.0".
4. Yes, GCP inspections will be also be added to the "Guidance for applicants”, as soon as GCP goes live (planned within a few weeks).

We are pleased to inform you that the EMA coordinated GMP Inspections feature has been added to the IRIS platform today, 21 September 2021. With the implementation of this new feature, Marketing Authorisation Applicants/Holders as well as EU/EEA inspectorates will be able to interact with EMA via a single portal, for GMP Inspections. This is expected to streamline the Inspection co-ordination process, ensure more secure information exchanges, and increase data quality through integration with other EMA master data systems (e.g. SPOR). GCP Inspections will be added shortly.

If you have any general questions about the IRIS feature on GMP Inspections, please post a new thread in the IRIS Forum “General Discussion and Self-Help”. If you have any technical problems with the new system, please raise a ticket at the EMA ServiceDesk. 

For more information please check the revised IRIS guide for Applicants.  

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. 
 

Dear Susanne,
Please find the answers inline

Question1-Do you have any guidance how to perform baseline submission for already authorised products?

We expect that MAHs provide a record for every presentation of a CAP that is currently in the market for every EU/EEE MS.
You can use the Marketing Status (single or bulk) submission for this.
For example, A CAP where presentations 001,002,003 are currently in the market in ES, PT, FR and DE and authorised presentations 004, 005 were never launched in any EU/EEA MS. 
Presentations 001,002,001 were first launched in ES and PT on the same date 01/01/1999, in FR on 01/02/1999 and on DE on 01/03/1999.

The database nor reflects: No DATA PROVIDED FOR all Presentations in all EU/EEA MS of a CAP.

You can report the baseline for this product in 2 ways:

OPTION 1: VIA Change in Mkt status (single):
Change in Mkt status (single): report that 001,002 and 003 STATUS: MARKETED Date of 01/01/1999 in ES and PT 
Change in Mkt status (single): report that 001,002 and 003 STATUS: MARKETED Date of 01/02/1999 in FR 
Change in Mkt status (single): report that 001,002 and 003 STATUS: MARKETED Date of 01/03/1999 in DE
Change in Mkt status (single): report that 001,002 and 003 STATUS: NON MARKETED in the rest of MS.
Change in Mkt status (single): report that 004, 005 STATUS: NON MARKETED in all MS.

OPTION 2: VIA Change in Mkt status (bulk):
You should fill the information as above in the rows of each presentation in each MS.
For 004,005, pls replace the Marketing status from  no data provided to non marketed 

Question 2 : Can you please advise how apply for corrections of products for e.g. under products/marketing status I can see a product for which my company is not the MAH.
Any case where you identify a CAP not belonging to your MAH, please report via Service desk(https://servicedesk.ema.europa.eu/jira/servicedesk/customer/portals) by creating a ticket

 

Users can now report the marketing status of centrally authorised medicines (CAPs) in the IRIS platform  from 26 July 2021.
For not yet marketed CAPs, MAHs will have to use the IRIS reporting system for the Marketing status and any subsequent changes in any EU/EEA country.

For already marketed CAPs, the regulatory deadline for MAHs to populate the marketing status of their products in IRIS is six months after launch (i.e. by 31/01/2022). Therefore, it is strongly recommended for companies to start using this new system as early as possible. During this implementing period, the current reporting system via emails and Excel sheets will co-exist with the new IRIS reporting system. 

Three submission types has been made to help user report changes: Marketing Status(Single), Marketing Status Withdrawals and Marketing Status (Bulk Upload)

For more information please check the revised IRIS guide for applicants and the revised Q&A on CAP marketing status updates and withdrawals.
 

Problem: some users of the IRIS industry portal have reported an occasional problem in the 'Safety Update' submission type, for Parallel distribution entitlements: not all filtering boxes are visible. Due to this, users are unable to filter the Regulatory Entitlements as desired, on the ‘Select regulatory entitlements’ page.

Investigation of the problem has suggested that the issue is related to the resolution of the user's screen, when visualising that page.

Workaround: if you experience the problem above, we suggest to zoom-out (Press Ctrl and - on the keyboard) on that page. Alternatively, you could change the resolution of your screen manually to increase it, or connect your computer to a larger screen.

If you still face difficulties, please raise a Service Desk ticket. 
 

IRIS industry portal users have reported an occasional problem when all mandatory fields have been filled in a ‘Request for research product’ submission, but the system returns an error ;  the substances keep on loading. This prevents the user from clicking on the ‘Save and Return’ button, thus blocking the progress of the submission.
Investigation of the events has suggested that the issue is related to cookies in the browser, as it could be resolved by changing browser and/or using private/incognito mode.
Solution- If the issue occurs; we suggest using the Chrome browser in incognito mode so that old cookies are not present in your session. Make a new request, or reopen the existing one, in incognito mode; add the missing details and click on “save and return”. If you still face issues after deleting cookies from the browser or opening a new session in chrome (incognito mode), please raise a Service Desk ticket

Industry Portal Changes

1. Bug fixed for ‘Clarification on SA’: The "Select previous advice" lookup is now working in the 'Clarification on SA' form. Users will be able to request and submit this submission type.
2. The ‘Age range' field is made mandatory in “Application for Orphan Designation” and  "Amendment of orphan designation" forms.
3. Workaround for error messages like ‘Message object reference error’ when creating a new submission:  many users have reported this error in the 'Choose submission Type' section, while drafting a new submission. Users are blocked by this error and cannot proceed further with the creation of the submission. After investigation, there seems to be no technical issue, but this appears to be a caching problem. The simple solution is to refresh the browser (F5). The error will disappear and the user can continue with the application.

Please find our responses to your questions:

Is it still planned to launch of marking status reporting in IRIS in the first week of December (this date is mentioned here in the forum)?
No. we do not have yet a fixed launch yet but we intend to launch I QTR 2021

Will there be a staggered roll-out? Meaning the newly granted MA first, followed by older authorised CP products?
Yes. We plan a staggered approach to be presented and discussed with Industry associations on EMA industry Platform meeting on centralised procedure on 3rd Dec 2020.

Will the launch data be available for the public?
The data will not be publicly available.

Will the use become immediately mandatory or optional?
There is a legal obligation to report marketing status to EMA. This constitutes a new way of reporting the marketing status to EMA.

Will marking status data of CP products be migrated or do users have the enter all dates?
Users will require to enter a baseline data for authorized products. These details are intended to be discussed and agreed with Industry associations on 3rd December

Will the same granularity be used as for the current EMA template/notification?
The level of granularity is similar.

Will training to be offered?
The system for data entry is very intuitive, similar to all other IRIS submissions. The IRIS guidance is being updated to include information on the new procedures. If needed, training could be considered.