Updated IRIS guide for applicants - Registering an i-SPOC

Marketing authorisation holders for all authorised medicines in the EU are required to appoint a so-called industry single point of contact (i-SPOC) who can provide information directly to EMA about the supply and availability of critical medicines identified in the context of a major event or a public health emergency. This applies to products authorised via any procedure, whether centrally via EMA, or using national, mutual recognition or decetralised procedures.

They need to register an i-SPOC by 2 September 2022.

For more information, please read the announcement on the EMA Corporate website.

Registering an i-SPOC

Marketing authorisation holders need to identify their i-SPOC via EMA's IRIS platform.

They can log in to IRIS using their EMA account credentials.

Guidance on how to register an i-SPOC is available in the demo video on the EMA Corporate website, and in the user guide on the IRIS platform. Marketing authorisation holders who do not have an EMA account need to create one first via EMA's Account Management portal. This could take 5-10 working days. For technical support, they should contact the EMA Service Desk.

Could you please clarify whether a MAH person who already has a "Industry Manager" role in IRIS can nominate himself for MAH i-SPOC? Or the nomination for i-SPOC should always be done by another MAH IRIS "manager" role?
 

Yes, a person with "Industry manager" role can nominate himself/herself for MAH i-SPOC (only consideration is that the user should be affiliated in IAM).
 

Could you please clarify whether the iSPOC should be nominated only for CAPs or also for MRP/DCP/National products authorised in EU? Thank you very much

As reported in the initial message of this thread:

Marketing authorisation holders for all authorised medicines in the EU are required to appoint a so-called Industry single point of contact (i-SPOC) who can provide nformation directly to EMA about the supply and availability of critical medicines identified in the context of a major event or a public health emergency. This applies to products authorised via any procedure, whether centrally via EMA, or using national, mutual recognition or decentralised procedures.

Even with Manager role, we don't have i-SPOC in the Submission Type list.  Shall I create an EMS ticket?

Dear Isabelle Picard, as reported in the Home page of these Forums, for access and registration requests and for reporting faults please open a request in EMA ServiceDesk providing as much information as possible (e.g. screenshots)

We have been trying to register a colleague nominated to represent my company as i-SPOC, but she has failed so far to register herself in the IRIS Manager role, even though one of our Administrators approved the request over two weeks ago. She has raised a request with the Service Desk last week but so far, there has no resolution. Given that the deadline for nominating i-SPOCS is only a few days away, and that will involve companies that hitherto will not have registered for Industry roles in IRIS (because their product portfolios do not contain CAP products) there is a real chance that the Service Desk will receive huge numbers of requests for assistance, and that many companies will fail to meet the September 2nd deadline!
Is there a pragmatic way of informing the Agency of the i-SPOC nominee ad-interim, perhaps if at least the EMA account credentials are shared?
Thanks