Paolo Tomasi EMA

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. 

Yes, unfortunately the link name retains the old version's number, the updated version number (2.4) is showing in the document. 
GCP is not released yet, due to unforeseen problems raised in UAT (User Acceptance Testing), which need some refactoring of the development; the guidance document is, as you say, pre-info, 

An updated version of the IRIS guide for applicants (how to submit) v1.8 (europa.eu) has been published in the IRIS portal (Guidance section). 

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. 

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. 

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