Questions on access to IRIS for Product Contacts (for Inspections procedures)

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.

We have received the email for IRIS registration for product contact. The email was addressed to a person who is not working anymore for Laboratoires S.M.B. Contact details were changed in 2020, so it's strange to receive email addressed to an old contact person.
Two persons have the role of Industry Manager for the ORG 100000498: myself and another person, so I suppose it's ok and we will receive information on inspection if necessary.
Could you please confirm?

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.

Could you please confirm whether the Product contact for the Marketing Authorisation Holder is the person included in the eAF in section 2.4.1 (Proposed marketing authorisation holder/person legally responsible for placing the product on the market in the European Union/each Member State) or the person included in section 2.4.3 (Person/company authorised for communication between the marketing authorisation holder and the competent authorities after authorisation)?

The Product contact in IRIS is integrated from the current EMA system to manage centralised procedures, SIAMED, where it is added from 2.4.3 (Person/company authorised for communication between the marketing authorisation holder and the competent authorities after authorisation).

See the previous reply in this thread on how to change the contact person for a product. 

In follow-up to this topic, would it possible to register a back-up contact person for CP product in SIAMED, so any future notification regarding inspection can be received by both contacts in IRIS?

The principle in IRIS is that only a single person/email address is maintained as contact person for a product, submission or regulatory entitlement. We plan to introduce, in the future, complete self-management of contact persons by applicants/marketing authorisation holders directly in the IRIS Industry  portal. This is already possible for any ongoing submission, since the submission contact can be changed directly by the applicant in the IRIS portal, and will be extended to products and regulatory entitlements (such as orphan designations) in the future. 
Alternatively, or additionally, applicants/marketing authorisation holders may wish to set their own autoforward rules on their mail server or individual email program. 

Would it be possible to download from IRIS (SIAMED) the list of products's contact point details, in the context of inspections procedure, for the organisations (MAHs) we act in behalf of?
To be able to check the list and if necessary notify changes would be able very helpful.


 

This feature is not available. As mentioned in the previous answer, the plan is to allow complete self-management of contact persons by applicants/marketing authorisation holders directly in the IRIS Industry  portal. 

In order to set up the auto-forward rule, could you please confirm if any inspection related notification will be sent out from the EMA-IRIS mail address  <EMA-IRIS@id.ema.europa.eu>? 

All email messages from IRIS are sent from the address EMA-IRIS@id.ema.europa.eu, including those for Inspection procedures. 

We have received this email in connection with an marketing authorization application. The person handling the correspodence with the EMA regarding this submission is an external regulatory service provider, would be possible to restrict access to IRIS (and the view of all other current and past submission) for such an external provider only to the submission regarding the marketing authorization?
Will only the person handling the correspondences with the EMA notified by email of a planned inspection or also the contact at the sponsor?

As already specified in the answers above, the principle in IRIS is that only a single person/email address is maintained as contact person for a product, submission or regulatory entitlement. For Inspection procedures, the contact initially assigned to the Inspection "submission" is the Product Contact as communicated by the Applicant to EMA during the Marketing Authorisation application. Also, as already mentioned above,  it is the responsiblity of the applicant:

1. to update the Product contact as required, at earliest possible convenience and using the procedure described above;
2. to notify other persons, in addition to the Product Contact, within or outside the Company in the preferred way (for example, using autoforward rules).