Dunja Vukic

There is no need for separate request for GMP/GCP/GVP inspections contacts.
The contact for GMP/GCP is the product contact as notified to EMA during the MAA or updated later and the contact for GVP is the QPPV as stated in the Art57/UPD so the EMA already holds that information.
 

Dear Ms Mulligan, thank you for your question.<br> <br> The information is taken from the field "QPPV E-mail Address" and it is connected to the QPPV's profile in the EMA account management system.&nbsp;<br> <br> We hope this clarifies.<br> <br> Kind regards,

GMP inspection submissions are created for the Marketing Authorisation Holders, whose users then have access to them. Manufacturing site organisations are not able to see the data in IRIS. Therefore the product contact only needs to be affiliated to the MAH organisation.

GVP Inspections are now in development and the switch to IRIS out is tentatively planned for September.
We will organise a dedicated training session before the go live and we will provide more information on that in July.
 

Dear Isha,<br> <br> The industry submissions for inspections are only accessible to Applicants/MAHs and fees are therefore charged only to Applicants/MAHs.<br> IRIS has not affected the way EMA works with fees for inspections and PO numbers.&nbsp;<br> <br> Kind regards,<br> Dunja

Please see the answers below:

• please open a Service Desk ticket and provide as much details as possible.
• It is planned for Q2.

I hope this clarifies.

Thank you for the question and apologies for the lack of notifications. One of my colleagues will e-mail you to discuss your questions and issues.
 

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.

Thank you for your questions.
 

• Yes, the user is the product responsible person notified to EMA (i.e. the product contact is also considered as the submission contact).
• Only the product contact (submission contact) will receive an automated e-mail message to the e-mail address they notified to EMA, saying that an inspection has been requested for their product. For all the details, the product contact (submission contact) will have to have an IRIS account and log into IRIS.
• We strongly encourage all product contacts to register with IRIS as soon as possible.
• There will be no information in IRIS until the notification.
• The product contact (submission contact) is able to add other colleagues as submission managers or contributors, provided that they have an IRIS account and an affiliation to the same parent company (applicant/MAH).
• Additionally, the product contact (submission contact) will also be able to transfer the role of submission contact, for that particular submission, to another submission manager associated to the submission. The submission contact is the person receiving emails from the IRIS system, for that particular submission. Please note that this does not change the product contact.