GMP Inspections in IRIS

Hi,

1. I have noticed that in the new IRIS guide for applicants v2.2, dated 17-Sep-2021, a new section has been added for GMP Inspections. It is stated that "Upon adoption of a GMP inspection request by the CHMP or CVMP, the user will receive a notification from EMA indicating that an inspection request has been adopted by the relevant committee (CHMP or CVMP) for one of their products. At that point, you must update the submission with the necessary information (e.g. Purchase Order number) and submit it via the IRIS Portal." Can you please specify who is meant by "the user" ? Who exactly receive the information ? 
    
2. Is there any training video available about this new feature?
    
3. Another new "Guidance for applicants/MAHs involved in GMP inspections coordinated by EMA Version 1.0" has also been released, what is the purpose of having a separate other guidance?
    
4. Will the GCP Inspections be added as well, and when?

Thanks,
Isha 

Please find answers to your questions below:

1. By "User" we mean the Product Contact for the centrally authorised product; this person becomes the Portal Contact (a.k.a. Submission Contact) for the Marketing Authorisation Holder/Applicant in the Inspection procedure.
2. The video recording of the training for Industry held on 10 September will be published shortly on the EMA IRIS website.
3. We are in process of removing the "Guidance for applicants/MAHs involved in GMP inspections coordinated by EMA Version 1.0".
4. Yes, GCP inspections will be also be added to the "Guidance for applicants”, as soon as GCP goes live (planned within a few weeks).

Thanks much for this feedback.  So we understand 2 contacts/users will receive the inspection notification for a specific product and will be able to access the IRIS portal for further next steps (e.g. nominate other contributors and managers). May I ask who is the Portal Contact (a.k.a. Submission contact) as I am not sure where this contact is mentioned in the MAA application form (which section?).
Many thanks in advance! 
Isabelle

Thank you for those answers. However, I have some more questions please:
1- From 1 October 2021 (last Friday), MAH and applicants need to use EMA's IRIS system to communicate with EMA on GMP inspections requested by the Agency’s scientific committees. The video recording of the training for Industry held on 10 September is still missing publication.

2- Our understanding is that if more than one product is in scope of the GMP inspection for one site, several product contact get the IRIS notification. Can you please confirm that all product contacts will have to enter the Purchase Order number, for each submission/product ?

3- What exactly will be charged on the PO number provided, e.g. only the inspection fees, or also travel and accommodation costs of the inspectors ? How can a company separate PO for inspection fees from PO for travel and accommodation costs of the inspectors ?

4- IRIS notification will be generic (assumption) and only to one person (as informed only to the Product Contact for the application already notified to EMA, which is often the portal contact as well), which is a risk in terms of speed and eventually availability of this person (if he/she is out of office). What is done to limit this risk? Can we provide to EMA a generic email address to be copied for all inspections notifications?

5- Will the exchange of information with inspectors be handled in IRIS (steps after submission of PO still not clear) ?

6- Will the GMP inspection report be handled in IRIS (still not clear)?

Thank you in advance,
Isha

 

sorry, one more:
7- Can we download all the information received in IRIS in relation to GMP inspection, for communication and coordination within the company different functions ?

Thank you for your questions.
Please find the answers below:
 

1. The training recording has now been published, please see https://iris.ema.europa.eu/homenews/
2. There will be one industry submission per MAH legal entity, no matter the number of products so one PO number per MAH legal entity.
3. The travel and accommodation costs are to be paid directly by the applicant/MAH to the inspectors’ authorities and according to the policy/requirements of the inspectors’ authorities which may vary amongst the Member States.
4. The announcement of inspections via the old procedure has also only been to the product contact so there is no change with the implementation of IRIS.
5. The applicant/MAH should contact the reporting inspector, as with the current procedure, to agree on the method of submission.
6. Sharing of reports will not change with IRIS: GMP inspection reports will not be shared with MAH/applicant. Inspectors will share the report directly with the manufacturing site.
7. There is no reporting possibility in the system, but the page printout in the browser can be used.

Thanks a lot for the detailed explanations. Nevertheless I have two additional questions that may be useful for a further interpretation of the "User" role for GMP inspections.
Referring to your above response to question 1 on the "User" definition it is well understood that the "User" is the product contact already mentioned in the application to EMA.

1. By "User" we mean the Product Contact for the application already notified to EMA, and the Portal Contact (a.k.a. Submission Contact) for the Marketing Authorisation Holder/Applicant.

Could you please confirm that for an existing registration the above referenced definition refers to the "Person authorized for communication between MAH and EMA", as provided in attachment 6.3 of the submission dossier (understood as the Submission Contact)? 
Furthermore, since the application  includes further contact persons e.g. "the authorized person for quality defects and batch recall" are there any plans to include this roles directly into IRIS for GMP inspections to allow a direct assignment?

Thanks in advance,

Guido 

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.

I would like to add to the question above. 
"IRIS notification will be generic (assumption) and only to one person (as informed only to the Product Contact for the application already notified to EMA", which is often the portal contact as well, which is a risk in terms of speed and eventually availability of this person (if he/she is out of office). What is done to limit this risk? Can we provide to EMA a generic email address to be copied for all inspections notifications?"
The answer from above is:
"The announcement of inspections via the old procedure has also only been to the product contact so there is no change with the implementation of IRIS."
The process has not changed but the tool is now different: email vs IRIS:
A received mail can be forwarded to a deputy or to a generic email address per rule; so in case of unavailibility of the contact person the announcement of inspections.
The announcement of inspections in IRIS can only be opened by the contact person, and only this contact person can add additional IRIS managers.
Is this understanding correct?
What is done to limit the risk of the contact person being ooo?
Will the new role "IRIS Industry Global Coordinator IRIS Industry Global Coordinator " be able to open the announcement in IRIS?

In answer to your questions:

Q: Can we provide to EMA a generic email address to be copied for all inspections notifications?
A: This is currently not possible. At present, product contacts are imported from SIAMED2. We intend to develop, in the future, a feature to allow direct self-management of product contacts by Industry in IRIS (this requires implementation of the Global Coordinator role, see below).  

Q: The announcement of inspections in IRIS can only be opened by the contact person, and only this contact person can add additional IRIS managers. Is this understanding correct?
A: Your understanding is correct. 

Q: What is done to limit the risk of the contact person being out of office?
A: EMA is unable to keep track of the absences of Industry contact persons. You are welcome to contact the Inspections Office for specific arrangements, should a prolonged absence of the contact person cause difficulties. 

Q: Will the new role "IRIS Industry Global Coordinator " be able to open the announcement in IRIS?
A: Yes, this will be one of the advantages of the new role. An "IRIS Industry Global Coordinator" will be able to manage every submission for the Organisation(s) he/she is affiliated to, with that role.