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IRIS receives the "Product contact" from the SIAMED2 database, where it corresponds to the "Person/Company authorised for Communication on behalf of the Applicant during the Procedure".
In IRIS procedures, only one "Submission contact " is maintained, for the purpose of communicating with the Applicant/Marketing Authorisation Holder. There is no plan to modify the system to enable communication with multiple individuals from the same organisation, for a single procedure/submission.
Of note, the "Submission contact" may be different for separate procedures, and it can be modified by the Applicant/Sponsor in the submission, any number of times, among the other Industry Managers associated to the submission.
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For technical issues, including assistance on a specific submission, please create a Servicedesk incident. Please attach screenshots of the submission data in the Industry Portal, to help Servicedesk staff identify the problem and find a solution.
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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:
- to update the Product contact as required, at earliest possible convenience and using the procedure described above;
- to notify other persons, in addition to the Product Contact, within or outside the Company in the preferred way (for example, using autoforward rules).
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All email messages from IRIS are sent from the address EMA-IRIS@id.ema.europa.eu, including those for Inspection procedures.
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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.
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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,
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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.
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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.
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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.