Paolo Tomasi EMA

Any notification for a new inspection will be forwarded to the Product contact for the Marketing Authorisation Holder, as recorded in the Agency's database (SIAMED). It is the responsibility of the Marketing Authorisation Holder to maintain this information up to date, for each authorised product.

You can find more information on how to update the Product contact here: Contacting EMA: post-authorisation | European Medicines Agency (europa.eu)  (section: Notifying EMA of changes to contact persons).Please note that it may take up to 10 days for the information to be updated in IRIS, and be used in any new inspection procedure.

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. 

Management of GMP Inspections in IRIS has been launched on 21 September and Inspections are now being announced via automatic notifications from IRIS to the product contacts. The same approach will apply for GCP Inspections, whose process will go live in the next weeks.

For each Inspection, a new “submission” is created for each Marketing Authorisation Holder / MA Applicant in IRIS, regardless of the number of products involved. To access this submission, and provide documents when requested, all product contacts must have an IRIS Industry Manager role, affiliated to the Marketing Authorisation Holder/applicant of the product.
If a product contact already has access to IRIS and is are affiliated as Industry Manager to the organisation location of the product, no further action is needed.

If a product contact does not have access to IRIS, or does not not have an affiliation to the Marketing Authorisation Holder / applicant, this should requested as soon as possible.

If unsure of the access status, it is possible to visualise it in the EMA Account Management System.

Please refer to the IRIS guide to registration for further information on how to request this access via the EMA Account Management System.

Please post any questions on access to IRIS for Product Contacts, in the context of Inspections, in this thread. 

Please do not post confidential information in this thread, or elsewhere in the IRIS Forums, such as names of individuals or references to submissions.

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. 

The applications managed in IRIS do not have downloadable forms: data are filled online in webpages. For further instructions, and a list of procedures that are managed in IRIS, please see the three main guidance documents available in the IRIS guidance webpage: 

• IRIS guide to registration
• IRIS guide to applicants (scientific applications)
• IRIS guide to parallel distribution applicants

The recording of the webinar has been published now, in the IRIS Guidance page: Training recording: EMA IRIS Inspections Industry training on GMP & GCP

The 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. 

It 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. 

You 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). 
 

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.