EMA Inspections GMP is available on IRIS portal from 21 September 2021

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.  

Dear Poonam
thank you so much for providing the news concerning GMP Inspections!

I would like to ask a question concerning
"Upon adoption of a GMP inspection request by the CHMP or CVMP, the user will receive a notification from EMA indicating that an inspection request has been adopted by the relevant committee (CHMP or CVMP) for one of their products."

The user is the product responsible person notified to EMA, correct?
Is it a pre-requisite for the notification that this user has already IRIS access or can the user request IRIS access after receipt of the notification per mail?
If the user needs access to IRIS prior to the notification, all responsible persons will request access.
In IRIS there is no relation between user = product responsible person and a product until the GMP inspection process starts, correct?

Kind regards, Susanne
 

Dear Poonam 

Following on from Susanne's question. Would "all IRIS admin users", and or "all IRIS managers"  or "all IRIS users (admin, manager and contributor) of the company receive an email from IRIS to notify of an inspection?

In an earlier response to Isha (https://iris.ema.europa.eu/forums/general-discussion/f9ed2c6b-7d1b-ec11-b76a-0003ff4a48b7)  you stated that the user is: Product Contact for the application already notified to EMA, and the Portal Contact (a.k.a. Submission Contact) for the Marketing Authorisation Holder/Applicant. Will they require to be admin or manager or contributor in the IRIS portal or would they receive the notification in their email even without IRIS access?

Would the company solely receive an email via the IRIS platform or would MAH contact person be notified via their email address?
Is there any other way that the MAH would receive the notification of an inspection (for example email to a user not registered in IRIS but registered as contact person for this company). 

Looking forward to hearing from you
Jolanda

Thank you for your questions.
 

• Yes, the user is the product responsible person notified to EMA (i.e. the product contact is also considered as the submission contact).
• Only the product contact (submission contact) will receive an automated e-mail message to the e-mail address they notified to EMA, saying that an inspection has been requested for their product. For all the details, the product contact (submission contact) will have to have an IRIS account and log into IRIS.
• We strongly encourage all product contacts to register with IRIS as soon as possible.
• There will be no information in IRIS until the notification.
• The product contact (submission contact) is able to add other colleagues as submission managers or contributors, provided that they have an IRIS account and an affiliation to the same parent company (applicant/MAH).
• Additionally, the product contact (submission contact) will also be able to transfer the role of submission contact, for that particular submission, to another submission manager associated to the submission. The submission contact is the person receiving emails from the IRIS system, for that particular submission. Please note that this does not change the product contact. 

I am already registered in IRIS as IRIS Manager user under my personal e-mail address (zaklina.korazija@pliva.com) while as a contact address for CPs I am responsible for, I am registered at EMA under our cumulative address (we chose cumulative instead personal to be sure if responsible person is out of office EMA notification is still received/checked on time). After I received (via our cumulative e-mail address) a notification from EMA indicating that an inspection request has been adopted by the relevant committee (CHMP or CVMP) for one of our products, I tried to see this notification in IRIS but unsuccessfully since in IRIS I am registered under my personal e-mail. Is it possible to add in my IRIS account additional e-mail (cumulative address registered as product contact address)? Or is there any other proposal how to see these IRIS notifications coming to our cumulative address?


 

For IRIS and IAM, an account corresponds to an email address. You can have more than one IAM/IRIS account, each using different emails, although this is not generally recommended as it can lead to complications and misunderstandings. For Inspections, your IRIS account (with the correct affiliation) must be associated to the same email of your product contact, otherwise you will not be able to visualise the relevant submission. You can check the status and affiliations of your account in the EMA Account Management System. 

Could you please confirm if the submission of GMP inspection will be created under the MAH organization or the manufacturing site organization ? Should the contact person have access in IRIS to both organizations or is the access to the MAH organization enough?

GMP inspection submissions are created for the Marketing Authorisation Holders, whose users then have access to them. Manufacturing site organisations are not able to see the data in IRIS. Therefore the product contact only needs to be affiliated to the MAH organisation.